[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jules Bordet Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":673},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,50,79,111,138,162,193,234,256,283,311,338,360,388,408,431,455,478,499,532,558,584,609,629,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629429","phase-2-scalp-cooling-for-preventing-alopecia-with-new-antibody-drug-conjugates-100629429",false,"NCT07474558","SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates","SCARLET-ICE","Inclusion Criteria:\n\n1. Female\n2. Age ≥ 18 years\n3. ECOG performance status (PS) 0-2\n4. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE \\\u003C 2)\n5. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour\n6. Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule\n7. Life expectancy \\> 6 months\n8. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n9. Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. Known pregnant and\u002For lactating women.\n2. Participant with a known significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study\n3. Active haematological malignancy diagnosis\n4. Known or suspected scalp metastases at screening\n5. Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)\n6. History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)\n7. Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)\n8. Known hypersensitivity to device cap materials or coolant\n9. Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement\n10. Participants who have already started treatment with an ADC prior to randomisation will be excluded, as scalp cooling must begin with the first ADC infusion","FEMALE","18 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this interventional study is to determine if scalp cooling (by the Paxman Scalp Cooling System) reduces the extent and severity of alopecia in participants with advanced solid tumours receiving ADC.\n\nThe main question it aims to evaluate the efficacy of scalp cooling in reducing chemotherapy-induced alopecia in participants with advanced\u002Fmetastatic solid tumours receiving antibody-drug conjugates (trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan), as assessed by blinded central dermatological review.\n\nResearchers will compare the experimental arm (ADC treatment + scalp cooling) with the control arm (ADC only). Scalp cooling will be done each day of ADC treatment : before, during and post-infusions of their ADC treatment.",[27,28,29],"Advanced or Metastatic Solid Tumour","Antibody-Drug Conjugate","Alopecia",[31,32,33,34,35,36],"ADC","Antibody-drug conjugates","advanced or metastatic solid tumour","scalp cooling","hair loss","alopecia","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":21},"2026-09",{"date":45,"type":21},"2031-09",{"name":47,"class":48},"Jules Bordet Institute","OTHER",3,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100651100","medical-imaging-to-re-evaluate-elacestrant-clinical-usage-100651100","NCT07753954","Medical Imaging to Re-evaluate Elacestrant Clinical Usage","Imaging to Re-evaluate Elacestrant Clinical Application","IRENA","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. ECOG performance status ≤ 1\n3. Must have histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease not amenable to therapy with curative intent or metastatic disease not amenable to curative therapy.\n4. Documentation of ER-positive (≥10% positive stained cells) and HER2 negative (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) advanced or metastatic breast cancer according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment. ER-positive\u002FHER2-negative status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease, where this might not possible.\n5. Must be appropriate candidates for endocrine monotherapy.\n6. Must have previously received no more than 1 line of endocrine therapy:\n\n   * a) Radiological or objective evidence of disease progression on prior treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy (either an aromatase inhibitor or fulvestrant) for advanced disease after at least 12 months of treatment.\n   * b) Patients receiving CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after finishing treatment with CDK4\u002F6 inhibitor but no more than 12 months following CDK4\u002F6 inhibitor treatment completion in this scenario, this will count as 1 line of ET for mBC.\n7. ESR1 mutation not detected, test performed after ET plus CDK4\u002F6 inhibitor. This local determination will be performed in blood using a validated assay.\n8. No contraindications to perform 18F-FES-PET\u002FCT.\n\n   \\- a) Patients will not be selected when treated with SERMs or SERDs ≤ 5 weeks prior to inclusion as these drugs interfere with the accessibility of the ER.\n9. Life expectancy ≥ 6 months.\n10. At screening FDG-PET\u002FCT at least two \"target\" lesions are required to fulfil the following criteria:\n\n    * a) anatomically transaxial diameter ≥ 1.5 cm AND\n    * b) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma.\n    * c) In case of suspected liver metastasis, a lesion should have a SUVmax ≥ 2 x SUVmean + 3 SD of the blood pool measured in a 1 cm-diameter VOI within descending thoracic aorta. Lesions pre-treated with irradiation are not eligible for consideration as \"target\" lesions.\n11. Female participants must be post-menopausal women, defined by 1 of the following criteria:\n\n    * a) Prior bilateral oophorectomy (≥ 28 days prior to Day 1 of treatment).\n    * b) Age ≥ 60 years with amenorrhea ≥ 1 year since last menses.\n    * c) Age \\\u003C 60 years: i. Cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; OR ii. serum oestradiol and\u002For FSH levels within the laboratory's reference range for post-menopausal females\n    * d) Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status must be concurrently receiving a LHRH analogue (goserelin), as per standard of care, for at least 28 days (if shorter, post-menopausal levels of serum oestradiol\u002FFSH must be confirmed analytically) prior to study enrolment and are planning to continue LHRH agonist treatment during the study.\n12. Resolution of all toxic effects of prior therapies or surgical procedures to Grade ≤ 1 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).\n13. Adequate organ function as defined below:\n\n    * a) Haematologic function: i. Absolute neutrophil count ≥ 1.0 x 109\u002FL. ii. Platelet count ≥ 75 x 109\u002FL. iii. Haemoglobin ≥ 9.0 g\u002FdL.\n    * b) Renal function: i. Estimated glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m2 or creatinine. clearance calculated by Cockcroft-Gault equation ≥ 30 mL\u002Fmin.\n    * c) Hepatic function i. Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN; in the presence of liver metastases, ALT ≤ 5x ULN).\n\n    ii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in participants with documented Gilbert's Syndrome.\n\n    \\- d) Chemistry i. Potassium, sodium, calcium (corrected for albumin), magnesium, and phosphorus NCI CTCAE v6.0 Grade ≤ 1. If screening assessments are abnormal, chemistry assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment (e.g., for hypercalcemia) prior to re-assessment e) Coagulation i. International normalized ratio (INR) ≤ 1.5\n14. Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.\n15. Signed Informed Consent Form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only:\n16. Affiliated to the French Social Security System (applicable only to participants treated in France)\n\nExclusion Criteria:\n\n1. Prior treatment with elacestrant, or an investigational SERD or ER antagonist.\n2. Prior chemotherapy for advanced or metastatic disease.\n3. Prior anti-cancer or investigational drug treatment within the following windows:\n\n   * a) Fulvestrant treatment (last injection) \\\u003C 5 weeks before first dose of study drug.\n   * b) Any other endocrine therapy \\\u003C 14 days before first dose of study drug.\n   * c) Chemotherapy or other anti-cancer therapy \\\u003C 21 days before first dose of study drug.\n   * d) Any investigational anti-cancer drug therapy \\\u003C 28 days or 5 half-lives (whichever is shorter) before the first dose of study drug.\n4. Radiation therapy (other than CNS directed) within 14 days before the first dose of study drug. CNS directed radiation therapy within 28 days before the first dose of study drug.\n5. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. Note: Patients with stable brain or subdural metastases are allowed if the subject has completed local therapy and was on a stable or decreasing dose of corticosteroids at pre-study treatment period baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. If anticonvulsant medication is required, participants must be stable on a non-enzyme inducing anticonvulsant regimen (Appendix 1).\n6. Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%.\n7. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).\n8. Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer.\n9. Any of the following within 6 months before enrolment: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v6.0 Grade ≥2, prolonged QTcF ≥ Grade 2 (i.e., \\> 480 msec), uncontrolled atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines, or cerebrovascular accident including transient ischemic attack.\n10. Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, participants with the following conditions will be allowed to participate:\n\n    * a) Adequately treated catheter-related venous thrombosis occurring \\> 28 days prior to the first dose of study drug.\n    * b) Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring \\> 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject.\n11. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass.\n12. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary\u002Fherbal supplements (e.g., St. John's wort), and\u002For foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity (Appendix 1). Participation will be allowed if the medication, supplements, and\u002For foods are discontinued for at least 5 half-lives or 14 days (whichever is longer) prior to initiation of study treatment study enrolment and for the duration of the study.\n13. Major surgery \\\u003C 28 days before the first dose of study drug\n14. Pregnant and\u002For lactating women, or intending to become pregnant during the study.\n15. Women of childbearing potential refusing to use 1 highly effective method of contraception prior study entry, during the course of the study and at least 120 days after the last administration of study treatment.\n16. Men with childbearing potential partner refusing to use condom during the course of this study and for at least 120 days after the last administration of the study treatment.\n17. Participant with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n18. Known hypersensitivity reactions to the study drugs or to any excipients.\n\n    Exclusion criterion applicable to FRANCE ONLY:\n19. Vulnerable persons according to the article L.1121-6 of the \"Code de la Santé Publique\" (CSP), adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP.","ALL",{"count":60,"type":21},160,[24],"The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4\u002F6 inhibitor.\n\nThe study aims to answer two key questions:\n\n* Does \\[18F\\]-fluor-oestradiol positron emission tomography\u002Fcomputed tomography (18F-FES-PET\u002FCT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced\u002Fmetastatic ER-positive breast cancer and ESR1-mut-nd?\n* Does 18F-FES-PET\u002FCT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response?\n\nThere is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET\u002FCT imaging.\n\nParticipants in the study will:\n\n* Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects).\n* Undergo 18F-FES-PET\u002FCT and 18F-FDG-PET\u002FCT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks\n* Undergo blood sample collection every 8 weeks\n* If selected for a sub-study, undergo an additional FES-PET\u002FCT scan 4 weeks after starting treatment",[64],"ER+ \u002F HER2- Advanced Breast Cancer",[66,67,68,69,70],"Advanced breast cancer","ER+","HER2-","Elacestrant","Imaging","2026-08-06",{"date":73,"type":41},"2026-08-10",{"date":75,"type":21},"2026-09-13",{"date":77,"type":21},"2031-08-19",{"name":47,"class":48},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100217003","aurora-aiming-to-understand-the-molecular-aberrations-in-metastatic-breast-cancer-100217003","NCT02102165","AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.","AURORA","Inclusion Criteria:\n\n1. Female or male ≥ 18 years with diagnosis of locally recurrent\u002Fadvanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.\n\n   Under protocol 4.0, eligible patients will be limited to locally recurrent\u002Fadvanced breast cancer not amenable to treatment with curative intent or MBC with:\n   * histopathology-confirmed TNBC as defined by ER \\\u003C1% and HER2 negative following ASCO-CAP guidelines\n   * ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC\u002Finvasive ductal carcinoma are not eligible for the ILC cohort.\n   * late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \\> 10 years from the primary BC diagnosis.\n2. Written informed consent prior to registration into the program.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n4. Availability of primary tumor tissue for research purposes.\n5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.\n\n   1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.\n   2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.\n   3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.\n6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.\n7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.\n8. Availability of a whole blood, serum and plasma samples collected at the time of screening.\n9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.\n\nExclusion Criteria:\n\n1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.\n2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.\n3. Presence of severe hematopoietic, renal, and\u002For hepatic dysfunction, including but not restricted to albumin \\\u003C 3 g\u002Fdl.\n4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.\n5. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.",{"count":87,"type":21},1000,[89],"NA","This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.\n\nIn summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the \"right therapy for each individual patient\". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.",[92],"Metastatic Breast Cancer",[94,95,96,97,98,99,100,101],"Aurora","breast cancer","metastatic","molecular screening","targeted gene sequencing","molecular aberrations","exploratory","biomarker","RECRUITING","2026-08-04",{"date":71,"type":41},{"date":106,"type":41},"2014-04",{"date":108,"type":21},"2031-03",{"name":47,"class":48},52,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":58,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100520112","efficacy-and-safety-of-conventional-neoadjuvant-therapy-versus-total-neoadjuvant-therapy-in-older-patients-with-locally-advanced-rectal-cancer-100520112","NCT06052332","Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer","Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial","SHAPERS","Inclusion Criteria:\n\n1. Age ≥ 70 years old\n2. ECOG performance status (PS):\n\n   * ≤1 if age \\> 75 years old\n   * ≤2 if age ≤ 75 years old\n3. Histologically or cytologically confirmed adenocarcinoma of the rectum\n4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge\n5. Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement\u002Fthreatening \\[i.e.,tumour within 1 mm of the MRF\\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible.\n6. Adequate bone marrow function as defined below:\n\n   * Absolute neutrophil count ≥1,500\u002FµL\n   * Haemoglobin ≥9 g\u002FdL\n   * Platelets ≥100,000\u002FµL\n7. Adequate liver function as defined below:\n\n   * Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \\\u003C3xUNL is allowed\n   * AST (SGOT) and ALT (SGPT) ≤2.5 x ULN\n   * Alkaline phosphatase ≤2.5 x ULN\n8. Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73m² (according to the CKD-EPI 2021 equation).\n9. Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and\u002For surgery.\n10. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n11. Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.\n\nExclusion Criteria:\n\n1. Extensive growth into cranial part of the sacrum (above S2\u002F3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved.\n2. Presence of metastatic disease or recurrent rectal tumour.\n3. Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0.\n4. Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n5. Any contraindication to pelvic irradiation as evaluated by the investigator.\n6. Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications.\n7. Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair).\n8. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment.\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months.\n10. Complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n11. Any previous treatment for rectal cancer.\n12. Use of brivudine, sorivudine or their chemically related analogues.","70 Years",{"count":121,"type":21},230,[89],"The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.",[125,126],"Locally Advanced Rectal Cancer","Older People",[128],"rectal cancer","2026-07-31",{"date":131,"type":41},"2026-08-03",{"date":133,"type":41},"2024-02-07",{"date":135,"type":21},"2033-12",{"name":47,"class":48},19,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100645386","randomized-clinical-investigation-of-photobiomodulation-pbm-for-the-management-of-early-peripheral-neuropathy-related-to-medical-oncologic-therapy-100645386","NCT07681921","Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy","ENL","Inclusion Criteria:\n\n* All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Be able to understand the ICF and study-related questionnaires\n* Signed informed consent\n\nExclusion Criteria:\n\n* severe or unstable cardio-respiratory or musculoskeletal disease\n* Peripheral neuropathy previous to chemotherapy\n* Receiving potentially neurotoxic therapies other than given for cancer treatment\n* Interruption of more than two consecutive laser treatments",{"count":146,"type":21},98,[89],"Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and\u002For burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and\u002For physical therapy is applied with limited success. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. PBM uses visible and\u002For (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with \" de novo \" early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.",[150],"Chemotherapy Induced Peripheral Neuropathy",[152],"photobiomodulation and peripheral neuropathy","2026-07-01",{"date":155,"type":41},"2026-07-02",{"date":157,"type":21},"2026-09-01",{"date":159,"type":21},"2028-12-31",{"name":47,"class":48},1,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":58,"minAge":170,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":49},"100644725","immune-fitness-in-older-patients-with-relapsed-and-refractory-multiple-myeloma-100644725","NCT07674498","Immune Fitness in Older Patients With Relapsed and Refractory Multiple Myeloma","Prediction of Response Related to IMmune Age T Cell Fitness in Elderly Patients With Relapsed and Refractory Multiple Myeloma","PRIME","Inclusion Criteria:\n\n* ≥ 65 years old\n* Relapsed\u002Frefractory multiple myeloma\n* Eligible for a CAR-T cell or bispecific antibody therapies\n\nExclusion Criteria:\n\n* \\\u003C65 years old\n* Active cancer other than myeloma\n* Active AL amyloidosis\n* Central nervous system (CNS) involvement","65 Years",{"count":172,"type":21},31,[89],"Relapsed\u002Frefractory multiple myeloma (RRMM) predominantly affects older adults, who exhibit marked heterogeneity in treatment outcomes despite receiving the same therapies. Clinical frailty scores, such as the International Myeloma Working Group (IMWG) Frailty Index, predict survival and treatment tolerance but provide limited information on immune competence, a key determinant of response to T-cell-based immunotherapies.\n\nThe PRIME study is a prospective, multicenter, non-interventional exploratory study designed to evaluate the relationship between immune fitness and clinical outcomes in patients aged 65 years or older with RRMM treated with standard-of-care chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies. Peripheral blood samples collected before treatment initiation will be analyzed to characterize T-cell differentiation, activation, senescence, exhaustion, and T-helper cell subsets using multiparametric immunophenotyping. Serum biomarkers, including soluble B-cell maturation antigen (sBCMA) and senescence-associated soluble markers, will also be assessed.\n\n* The primary objective is to determine whether baseline immune profiles are associated with quality of response at 3 months after treatment initiation.\n* Secondary objectives include evaluating the association between immune profiles and treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), other neurological toxicities, and infectious complications. Exploratory analyses will integrate immune, geriatric, sarcopenia, and clinical variables using statistical approaches to identify novel predictors of efficacy, survival, and toxicity.\n\nBy combining immune phenotyping with frailty assessment, the PRIME study aims to improve biological risk stratification and support the development of more personalized treatment strategies for older patients with multiple myeloma.",[176],"Myeloma Multiple",[178,179,180,181,182,183,184],"multiple myeloma","immunosenescence","Exhaustion","T-fitness","T lymphocyte","elderly","T cell therapies","2026-06-24",{"date":187,"type":41},"2026-06-29",{"date":189,"type":41},"2026-06-03",{"date":191,"type":21},"2027-09",{"name":47,"class":48},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100638324","pregnancy-outcomes-after-breast-cancer-in-young-women-with-germline-pathogenic-variants-in-genes-other-than-brca-100638324","NCT07591532","Pregnancy Outcomes After Breast Cancer in Young Women With Germline Pathogenic Variants in Genes Other Than BRCA","Retrospective Observational Study on the Prognostic Impact of Pregnancy in Young Women With Breast Cancer Harboring a Germline Pathogenic Variant in Breast Cancer-related Genes Other Than BRCA1\u002F2: the \"Beyond BRCA BCY Collaboration\"","Beyond BCY","Inclusion Criteria:\n\n* Diagnosis of stage I-III invasive breast cancer between January 2000 and December 2025\n* Age at breast cancer diagnosis ≤40 years\n* Germline pathogenic variant in at least one of the following breast cancer susceptibility genes other than BRCA: TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, or RAD51D\n\nExclusion Criteria:\n\n* Known germline pathogenic variant in breast cancer susceptibility genes without a diagnosis of invasive breast cancer\n* Diagnosis of ovarian cancer or other malignancies without a prior history of invasive breast cancer\n* Diagnosis of invasive breast cancer with germline variants of uncertain significance in breast cancer susceptibility genes\n* De novo stage IV breast cancer","40 Years",{"count":203,"type":21},2200,"OBSERVATIONAL","The present study aims to refine the understanding of the prognostic impact of pregnancy after breast cancer in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA",[207,208],"Breast Cancer","Breast Cancer and Pregnancy",[95,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225],"Pregnancy","Young Women","Hereditary Breast Cancer","Germline Pathogenic Variants","Breast Cancer Susceptibility Genes","Oncofertility","TP53","PALB2","PTEN","CDH1","STK11","CHEK2","ATM","BARD1","RAD51C","RAD51D","2026-05-11",{"date":228,"type":41},"2026-05-15",{"date":230,"type":21},"2026-06",{"date":232,"type":21},"2030-12",{"name":47,"class":48},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":241,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100556325","salvage-stereotactic-body-radiotherapy-of-the-prostate-bed-for-biochemical-recurrence-after-radical-prostatectomy-100556325","NCT06523634","Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.","STEREOBED","INCLUSION CRITERIA\n\n1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.\n2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng\u002FmL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \\>0.1 ng\u002FmL , or three consecutive PSA rises)\n3. WHO PS 0-1\n4. Age ≥18 years\n5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry\n6. Ability to understand and answer the EPIC-26 form in one of the languages available\n\nEXCLUSION CRITERIA\n\n1. Patients with a pT4 tumor at prostatectomy\n2. Patients with previously pathologically confirmed N1\n3. Patients with macroscopically involved margin at surgery (R2)\n4. Patients with a history of distant metastases\n5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \\>1cm and\u002For positive on PSMA without other explanation, are considered as a pelvic recurrence.\n6. Latest PSA \\> 2ng\u002Fml\n7. Patients with a IPSS \\>20\n8. Gleason 10 tumor\n9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate\n10. Prior pelvic radiotherapy\n11. Prior hormonal therapy started more than 6 weeks before randomization\n12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.\n13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.","MALE",{"count":243,"type":21},284,[89],"This is a a randomized phase II\u002FIII trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.",[247],"Prostate Cancer",{"date":249,"type":41},"2026-05-12",{"date":251,"type":41},"2024-12-10",{"date":253,"type":21},"2032-02-01",{"name":47,"class":48},13,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":58,"minAge":264,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":161},"100627953","phase-2-flash-radiotherapy-for-skin-cancer-100627953","NCT07455331","Flash Radiotherapy for Skin Cancer","Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Participants With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma","LANCE","Inclusion Criteria:\n\n1. Signed study Informed Consent Form\n2. Karnofsky Performance Status (KPS) ≥ 60\n3. Age ≥ 60 years\n4. Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM\n5. Participants requiring radiotherapy treatment according to the dermato-oncology tumor board: participants who cannot undergo surgical procedure or participants who decline surgical resection, and\u002For anatomical locations where surgery can compromise function or cosmesis.\n6. T1-N0 lesions (TNM UICC, 8th Edition)\n7. Lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). Lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. Lesions located on the scalp can be treated\n8. In cases of prior intervention within the target area, the treated lesion must be located at a distance of \\> 4 cm from the previous site.\n\nExclusion Criteria:\n\n1. Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated\n2. Concomitant auto-immune disease with skin lesions\n3. Concomitant use of radio-sensitizer drug\n4. Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study\n5. Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before EOT visit)\n6. Concomitant use of systemic or immunochemotherapy for skin cancer(s)\n7. Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)\n8. Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period.\n9. Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy).\n10. Uncontrolled intercurrent comorbidities that may impair wound healing including Diabetes Mellitus (HbA1c \\> 8.5% or evidence of active diabetic ulceration), Chronic Venous Insufficiency with active venous ulcers, or severe (Grade 3+) oedema in the treatment field.","60 Years",{"count":266,"type":21},60,[24],"The goal of this clinical investigation is to describe and compare the toxicity and efficacy of an experimental radiotherapy, named FLASH therapy, to conventional radiotherapy for subjects suffering from localized Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy can deliver the irradiation dose within milliseconds instead of the minutes commonly required in conventional radiotherapy, with the aim of providing a curative dose while minimizing side effects on healthy tissue.\n\nThis is a phase II selection and monocentric clinical investigation with a 1 to 1 randomization. This clinical investigation will include approximately 60 participants aged ≥ 60 years old with one or more localized cSCC and BCC who either cannot undergo surgery or decline surgical resection.\n\nThe study design is the following:\n\n* On day 1, either a single dose FLASH radiotherapy (22 Gy) will be delivered or a single dose conventional radiotherapy (22 Gy) will be delivered to the selected localized cSCC or BCC lesion(s) (up to maximum 3 per participant; all lesions distant of at least 4 cm from one-another).\n* The surveillance period will be of 6 weeks post irradiation.\n* Follow-up visits will take place at 3, 6, and 12 months post-treatment.",[270,271],"Cutaneous Squamous Cell Carcinoma (CSCC)","Basal Cell Carcinoma (BCC)",[273,274,275],"radiotherapy","FLASH","skin cancer","2026-05-06",{"date":226,"type":41},{"date":279,"type":21},"2026-06-23",{"date":281,"type":21},"2030-12-23",{"name":47,"class":48},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":58,"minAge":4,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":293,"conditions":294,"keywords":299,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":161},"100629388","integrating-peritoneal-histological-growth-patterns-into-preoperative-decision-making-for-colorectal-peritoneal-metastses-100629388","NCT07474025","Integrating Peritoneal Histological Growth Patterns Into Preoperative Decision-Making for Colorectal Peritoneal Metastses","Integrating Peritoneal Histological Growth Patterns Into Preoperative Decision-Making for Colorectal Peritoneal Metastses: A Prospective Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed colorectal adenocarcinoma\n* Suspected or confirmed peritoneal metastases from colorectal cancer based on imaging or prior clinical evaluation\n* Patients undergoing staging laparoscopy and\u002For cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) as part of standard clinical care\n* Availability of peritoneal metastasis tissue samples suitable for histopathological analysis\n* Written informed consent provided for participation in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Peritoneal metastases originating from non-colorectal primary tumors\n* Absence of available or adequate peritoneal metastasis tissue samples for histological growth pattern analysis\n* Patients who decline or withdraw informed consent\n* Patients unable to provide informed consent","100 Years",{"count":292,"type":21},30,"Colorectal cancer (CRC) remains the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related death, with approximately 15% of patients presenting with synchronous liver metastases (LM) and 7% with peritoneal metastases (PM) at diagnosis. Despite curative-intent resection of the primary tumor, 16-20% of patients subsequently develop metachronous LM and up to 19% develop PM within three years \\[1-5\\].\n\nSurgery remains the only potentially curative treatment for patients with colorectal peritoneal metastases (CRPM), offering long-term (\\>10years) disease-free survival (DFS) in a subset of highly selected patients \\[6,7\\]. However, selecting candidates for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) remains challenging and requires balancing the potential oncologic benefit of complete cytoreduction against perioperative risks and postoperative morbidity \\[6-8\\].\n\nConsequently, strong prognostic markers-clinical, biological, or genetic-are crucial to refine surgical decision-making. Currently, the two most consistent clinical determinants of outcome are the extent of disease (Peritoneal Cancer Index, PCI) and the completeness of cytoreduction (CC-score) \\[6-8\\]. Over the last decade, surgical selection has become more restrictive (e.g., PCI threshold moving from 25 to 17), and molecular profiles such as BRAF mutations have been associated with poor outcomes, potentially guiding against aggressive surgery in selected cases \\[8,9\\]. Yet, these markers are insufficient to fully capture inter-patient heterogeneity and do not reliably individualize surgical benefit \\[8,9\\].\n\nIn colorectal liver metastases (CRLM), the histological growth pattern (HGP) at the tumor-liver interface has emerged as a robust prognostic biomarker, with the desmoplastic HGP (d-HGP) associated with superior survival compared with replacement or pushing patterns \\[10,11\\]. International consensus guidelines have standardized HGP scoring for CRLM, enabling reproducible assessment and cross-study comparison \\[12\\]. Large multicentric cohorts also suggest possible modulation of HGP by systemic chemotherapy, supporting its value as a marker of intrinsic tumor biology and treatment response \\[13,14\\].\n\nTransposing this concept to the peritoneum, our group identified two reproducible peritoneal HGP in colorectal peritoneal metastases: the pushing pattern (P-HGP) and the infiltrating pattern (I-HGP). Across two monocentric studies, a dominant P-HGP (\\>50-60% of the tumor-peritoneum interface) was strongly associated with prolonged disease-free and overall survival (OS) \\[15,16\\].\n\nTaken together, these findings support HGP of PM as a potential histological biomarker to refine patient selection for CRS ± HIPEC beyond current clinical and molecular criteria.\n\nHowever, existing data derive exclusively from retrospective single-center cohorts, underscoring the need for prospective validation to:\n\nConfirm the independent prognostic value of HGP of PM (for overall and disease-free survival) in contemporary clinical practice; Standardize sampling and pathological assessment (standard operating procedures, central review, and interobserver reproducibility studies); Develop and validate a histo-prognostic scoring system integrating PM HGP with relevant clinicopathological variables, aimed at predicting patient outcomes and supporting preoperative decision-making for CRS ± HIPEC candidacy.\n\nThis prospective cohort study is designed to address these objectives without modifying standard care. By collecting clinicopathological and survival data prospectively, it will provide robust evidence for the integration of HGP into a multivariable prognostic model capable of stratifying surgical candidates and guiding individualized treatment strategies.",[295,296,297,298],"Peritoneal (Metastatic) Cancer","Colorectal Cancer","Colorectal (Colon or Rectal) Cancer","Histopathological Growth Patterns (HGPs)",[300,301,302],"Peritoneal cancer","Colorectal cancer","Histopathological Growth Patterns","2026-03-11",{"date":305,"type":41},"2026-03-16",{"date":307,"type":21},"2026-03",{"date":309,"type":21},"2028-12",{"name":47,"class":48},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":318,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":321,"studyType":204,"phases":4,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":337,"locationsCount":161},"100627657","ventral-hernias-following-cytoreductive-surgery--incidence-risk-factors-and-surgical-management-100627657","NCT07451483","Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.","Incidence, Risk Factors and Surgical Management of Incisional Hernias Following Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: A Retrospective Monocentric Cohort Study","Inclusion Criteria:\n\n* All adult patients (≥18 years) who underwent CRS +\u002F- HIPEC for PMP, colorectal and ovarian PC between 01 January 2010 and 31 December 2024.\n\nExclusion Criteria:\n\n* Patients with a prior history of ventral hernia at the planned incision site.\n* Patients undergoing CRS +\u002F- HIPEC for primary cancer other than PMP, colorectal and ovarian PC.\n* Patients with incomplete medical records preventing data extraction.\n* Patients lost to follow-up within one year of surgery.",true,{"count":320,"type":21},500,"1 Year","Cytoreductive surgery (CRS), with or without hyperthermic intraperitoneal chemotherapy (HIPEC), is currently the standard treatment for advanced peritoneal tumors, including pseudomyxoma peritonei (PMP), colorectal, and ovarian peritoneal carcinomatosis. This complex surgical approach involves extensive resections to remove all visible tumor deposits, often followed by heated intraperitoneal chemotherapy to target residual microscopic disease. While CRS ± HIPEC has been shown to improve survival, it is associated with significant postoperative morbidity, particularly affecting the abdominal wall. One of the most frequent and clinically relevant complications is the development of ventral (incisional) hernias, which can reduce quality of life, limit physical activity, and sometimes require additional surgical repair.\n\nThe incidence, risk factors, and optimal management of ventral hernias after CRS ± HIPEC remain incompletely defined. Reported incidences vary widely, likely due to differences in surgical techniques, patient populations, definitions of hernia, and follow-up duration. Known contributing factors include extensive laparotomies, multiple resections, tissue fragility induced by hyperthermic chemotherapy, and patient-specific factors such as age and body mass index. Additionally, management strategies for ventral hernias are heterogeneous, ranging from direct fascial closure to reinforcement with synthetic or biological meshes, using different surgical approaches (onlay or sublay), with limited evidence in oncologic settings.\n\nThis single-center retrospective observational study at the Institut Jules Bordet aims to provide a comprehensive analysis of ventral hernia occurrence, risk factors, and management following CRS ± HIPEC. Adult patients who underwent CRS ± HIPEC for PMP, colorectal, or ovarian peritoneal carcinomatosis between January 1, 2010, and December 31, 2024, were included. Patients with prior ventral hernias, incomplete follow-up (\\\u003C12 months), missing data, or interrupted CRS due to extensive disease were excluded. Hernias were identified via clinical examination and imaging studies (CT or MRI), and classified as early (\\\u003C12 months) or late (\\>12 months) postoperative events. Patients were categorized according to the presence or absence of ventral hernias at the incision site.\n\nThe primary objective of the study is to determine the incidence of incisional hernias following CRS ± HIPEC. Secondary objectives include (1) identification of patient-related and surgical risk factors associated with hernia development, and (2) analysis of institutional surgical management strategies, including type of repair and timing of intervention. Data were collected retrospectively from medical records, and statistical analyses include descriptive statistics, survival analysis, and univariate and multivariate regression to identify independent risk factors for hernia development.\n\nThis study is expected to provide valuable insights into the epidemiology, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, contributing to improved postoperative care, informed surgical planning, and potentially guiding institutional and international recommendations for hernia prevention and repair in this high-risk population.\n\nThis study aims to provide a comprehensive understanding of the occurrence, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, which may help guide surgical practice and improve postoperative outcomes.",[324,325],"Ventral Hernias","Cytoreductive Surgery",[324,325,327,328,329,330],"HIPEC","Surgical Management of Ventral Hernias","Peritoneal Metastasis of Ovarian or Colorectal Cancer, Pseudomyxoma Peritonei","Peritoneal Carcinomatosis","2026-02-28",{"date":333,"type":41},"2026-03-05",{"date":335,"type":41},"2026-01-20",{"date":307,"type":21},{"name":47,"class":48},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":241,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":161},"100603958","early-phase-1-testosterone-supplementation-in-patients-in-best-supportive-care-impact-on-quality-of-life-100603958","NCT07143279","Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life","TestoSup","Inclusion Criteria:\n\n1. Male hypogonadal with total testosterone \\\u003C 231 ng\u002Fdl in best supportive care with no further therapeutic options and who do not wish to be reanimated.\n2. Age ≥ 18 years old\n3. Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure.\n\nExclusion Criteria:\n\n1. Untreated prostate cancer, given the risk of epiduritis.\n2. Known hypersensitivity reactions to the study drug or to any excipients.\n3. Known allergies to peanuts or soya.",{"count":346,"type":21},20,[348],"EARLY_PHASE1","This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone \\\u003C 231 ng\u002FdL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation.\n\nCurrently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation.\n\nThe Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment\u002Fprocedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.",[351,352],"Hypotestosteronism","Palliative Care","2026-02-11",{"date":355,"type":41},"2026-02-13",{"date":353,"type":41},{"date":358,"type":21},"2027-11",{"name":47,"class":48},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},"100587253","stereotactic-radiotherapy-for-oligoprogressive-erher--metastatic-breast-cancer-a-prospective-phase-2-study-oligopro-breast-100587253","NCT06925984","Stereotactic Radiotherapy for Oligoprogressive ER+\u002FHER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)","The Oligopro-Breast Study: Stereotactic Radiotherapy for Oligoprogressive ER+\u002FHER- Metastatic Breast Cancer, a Prospective Phase 2 Study","Inclusion Criteria:\n\n* ECOG performance status 0-2.\n* Histologically confirmed ER+\u002FHER2- MBC.\n* History of polymetastatic disease. Patients with genuine oligometastatic disease and 1-3 oligoprogressive lesions are only allowed if ablative therapy of all metastases is deemed impossible.\n* Under 1st to 2nd systemic treatment line with hormonotherapy and\u002For CDK4\u002F6 inhibitors for at least 6 months before progression.\n* Progressive disease at 1-3 extracranial sites.\n* Ability to treat all progressive lesions locally according to the treating radiation oncologist.\n\nExclusion Criteria:\n\n* Second malignancy if it is not in complete remission.\n* Previous local treatment for oligoprogression under the current systemic treatment line\n* Current progression in a lesion that has been treated with SBRT before and is not amendable for surgery or radiofrequency ablation (RFA).\n* Progressive or newly diagnosed brain metastases. Known brain metastases that have been nonprogressive for at least 6 months, are not an exclusion criterion.\n* Inability to continue the same ST line after local therapy (for example because of toxicity or patient refusal).\n* Pregnancy.\n* Inability to sign the informed consent.",{"count":368,"type":21},48,[89],"The Oligopro-Breast trial is a Phase II study targeting women with ER+\u002FHER2- metastatic breast cancer who have been on endocrine therapy and\u002For CDK4\u002F6 inhibitors for at least 6 months, and show progressive disease at 1-3 extracranial metastases, which are treatable locally. The trial aims to investigate if treating these resistant metastases with SBRT (or other local treatments if SBRT is not possible) can extend the use of the current systemic therapy.\n\nPatients will continue their existing systemic treatment while receiving SBRT on all progressive lesions. If new oligoprogression occurs, SBRT will be performed again. A new systemic treatment line will start if there is polyprogression (more than 3 lesions at once), progression of more than 6 lesions over 12 months, intracranial progression, or lesions that cannot be treated locally.\n\nThe scientific question is whether local treatment of resistant metastases can prolong the effectiveness of ongoing systemic therapy, which is particularly beneficial if the treatment is well-tolerated. The primary objective is to measure the proportion of patients surviving without changing their systemic treatment line at 6 months after SBRT.\n\nThis trial is significant for patients as it explores a method to potentially extend the duration of effective and well-tolerated treatments, offering hope for better management of metastatic breast cancer.",[372],"OligoProgressive Metastatic Disease",[374,375,376,377,378,273],"Oligoprogression","metastatic breast cancer","CDK4\u002F6 inhibitors","SBRT","SABR","2026-01-30",{"date":381,"type":41},"2026-02-02",{"date":383,"type":41},"2025-10-30",{"date":385,"type":21},"2030-05-01",{"name":47,"class":48},5,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":241,"minAge":4,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":161},"100621436","lutetium-177-dosimetry-as-a-predictive-biomarker-of-response-in-metastatic-prostate-cancer-patients-treated-with-psma-radioligand-therapy-100621436","NCT07370597","LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.","LUDOPATH","Inclusion Criteria:\n\n* Male aged ≥18 years with adenocarcinoma of the prostate.\n* Progressive metastatic prostate cancer (progression defined as two consecutive increases of PSA, or progression by bone scan or by RECIST1.1).\n* Candidate for 177Lu-PSMA-RLT, with at least one lesion showing significant PSMA uptake (uptake higher than liver physiologic activity).\n* Able to start treatment within four weeks of baseline PSMA PET\u002FCT.\n* Willing and able to comply with all study requirements",{"count":396,"type":21},110,"A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET\u002FCT scan. Gafita et al. Data have shown that PSA and PSMA perform equally in assessing response to 177Lu-PSMA treatment, and their changes after two cycles are related to patient survival. After two cycles, patients with no PSA or PSMA response had worse outcomes than those with partial response or stable disease . That means PSA and PSMA changes after two cycles can be used as a surrogate of patient outcome. However, the explanation of disease resistance to 177Lu-PSMA-RLT is not yet fully understood. Inappropriate dose administration might be one of the possible explanations. A dose-response relationship has been established in radiotherapy , making dosimetry a standard of care in conventional radiotherapy. In the radionuclide therapy settings, the dose-response relationship has been reported in a multi-center phase 2 trial on the selective internal radiotherapy in hepatocellular carcinoma. In this context, calculating the absorbed dose to tumour lesions could be an excellent method to individualize radionuclide therapy to achieve a maximal response to treatment. If dosimetry calculations could predict which patients would ultimately respond or not respond to treatment, administered dose and number of 177Lu-PSMA-RLT cycles could be adapted early during the treatment course. In this context, our study aims to analyze if absorbed tumour dose obtained by dosimetry calculations could be used as a biomarker to predict non-response to treatment early after one cycle, as the first step towards treatment dose adaptation of a personalized radionuclide treatment approach.",[399],"Prostate Cancer (Adenocarcinoma)","2026-01-19",{"date":402,"type":41},"2026-01-27",{"date":404,"type":21},"2026-02-01",{"date":406,"type":21},"2027-12",{"name":47,"class":48},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100370882","a-brain-metastases-research-platform-to-tackle-the-challenge-of-cns-metastases-in-solid-tumours-100370882","NCT04109131","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program","BrainStorm","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Female or Male\n4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).\n\n   Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program\n\n   Seven cohorts of subjects are defined in this prospective multicenter study:\n   * Cohort 1: Triple negative breast cancer (TNBC)\n   * Cohort 2: HER 2 positive breast cancer (HER2+ BC)\n   * Cohort 3: Non-small cell lung cancer (NSCLC)\n   * Cohort 4: Small cell lung cancer (SCLC)\n   * Cohort 5: Melanoma\n   * Cohort 6: Other solid tumours (apart from the above mentioned subtypes\n   * Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis\n5. Availability of either primary and\u002For non-CNS metastatic archival tumour tissue is mandatory for inclusion.\n6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications\n7. Predicted life expectancy \\> 3 months.\n8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment\n9. Effective contraception is in place for women of childbearing potential\n10. Completion of all necessary screening procedures within 28 days prior to enrolment.\n11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n12. Affiliated to the French Social Security System\n\nExclusion Criteria:\n\n1. Pregnant and\u002For lactating women.\n2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.\n3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n\n   Exclusion criterion applicable to FRANCE only\n4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",{"count":417,"type":21},600,[89],"Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.\n\nBetter knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.\n\nIn this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.",[421],"CNS Metastases","2026-01-02",{"date":424,"type":41},"2026-01-06",{"date":426,"type":41},"2020-07-01",{"date":428,"type":21},"2029-01",{"name":47,"class":48},17,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":161},"100602114","molecular-imaging-of-cancer-associated-fibroblasts-in-glioblastoma-a-fapi-petmr-study-100602114","NCT07119294","Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET\u002FMR Study.","GlioFAPI","Inclusion Criteria:\n\n* Age above or equal to 18 years\n* Patients with a brain lesion suspected of glioblastoma based on neuroimaging data or patients with suspected recurrence of glioblastoma\n* ECOG performance status ≤ 3\n* Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\nExclusion Criteria:\n\n* Pregnant and\u002For lactating women.\n* Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n* Claustrophobic patient\n* Known hypersensitivity reactions to the FAPI or to any excipients, or to gadolinium-based contrast agents (GBCAs).",{"count":439,"type":21},50,[89],"Glioblastoma is a highly aggressive and malignant form of brain cancer that arises from the glial cells of the brain. It is the most common and deadliest type of primary brain tumor in adults, with a very poor prognosis and a low survival rate. Glioblastoma is characterized by rapid and uncontrolled growth, infiltrative invasion into surrounding brain tissue, and resistance to standard treatments. Therefore, new therapeutic strategies are highly needed. A subpopulation of fibroblasts called \"cancer-associated fibroblasts\" (CAFs) is know to be a key constituent of tumor stroma in several non-CNS tumors (e.g., breast, colon, lung,ovarian, or pancreatic cancers) . These CAFs express a specific protein called \"fibroblast activation protein\" (FAP), which is usually not expressed in healthy adult mammalian tissues. FAP has been shown to be elevated in vitro and in situ in glioblastoma cells , suggesting that CAFs expressing FAP might also play a functional role in malignant brain tumors. This research project aims at better characterizing the links between areas of increased FAPI uptake within glioblastomas and the local level of tumor aggressiveness. This will be done by comparing the distribution of their anatomical locations uptake within the tumor with the distribution of the uptake of other markers of local tumor aggressiveness such as amino-acid PET (FET), and MRI measures of cerebral blood flow such as arterial spin labelling (ASL) or perfusion-weighted echo-planar images . Ultimately, when possible, neuroimaging data will be compared with pathology findings from targeted brain biopsy samples or material from ablative surgery. Furthermore, this study will provide the necessary first step towards more large scale studies evaluating the potential use of 177Lu-FAPI as therapeutic agent in glioblastoma.",[443],"Glioblastoma",[445,446],"glioblastoma","FAPI PET\u002FCT","2025-08-06",{"date":449,"type":41},"2025-08-13",{"date":451,"type":21},"2025-08",{"date":453,"type":21},"2028-06",{"name":47,"class":48},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":161},"100601357","the-role-of-the-imaging-fapi-petct-in-exploring-the-microenvironment-of-colorectal-cancer-liver-metastases-100601357","NCT07109440","The Role of the Imaging FAPI PET\u002FCT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases","The Role of FAPI PET\u002FCT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study","FOAM","Inclusion Criteria:\n\n* Age above 18 years.\n* Liver metastasis on standard imaging for the initial assessment (MRI, FDG PET\u002FCT)\n* Naïve for treatment or after neoadjuvant chemotherapy\n* Scheduled for liver metastasis resection\n* ECOG Performance status ≤2.\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Non-resectable liver metastases\n* Pregnant and lactating women\n* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.",{"count":439,"type":21},[89],"FAPI PET\u002FCT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET\u002FCT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery",[467],"Liver Metastases From Colorectal Cancer",[469,446,470,471],"liver metastases from colorectal cancer","HGP","CAF",{"date":473,"type":41},"2025-08-07",{"date":475,"type":41},"2025-05-09",{"date":309,"type":21},{"name":47,"class":48},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":161},"100520661","phase-2-psma-petct-to-assess-the-expression-of-specific-membrane-antigen-psma-in-patients-with-progressive-triple-negative-breast-cancer-100520661","NCT06059469","PSMA-PET\u002FCT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.","PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET\u002FCT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.","PRISMA","Inclusion Criteria:\n\n* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure\n* Women with ≥ 18 years-old\n* Eastern Cooperative Oncology Group Performance Status of 0 to 2\n* Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET\u002FCT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET\u002FCT.\n* Radiolabelled PSMA PET\u002FCT has to be performed before the next treatment line initiation\n\nExclusion Criteria:\n\n* Pregnant or lactating patients\n* Other active neoplastic disease\n* Treatment by another molecule that is the object of investigation within 30 days\n* Skin only metastatic disease\n* Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study",{"count":346,"type":21},[24],"This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET\u002FCT imaging in mTNBC lesions pre-identified on 18F-FDG PET\u002FCT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.",[490],"TNBC - Triple-Negative Breast Cancer","2025-07-15",{"date":493,"type":41},"2025-07-18",{"date":495,"type":41},"2022-05-30",{"date":497,"type":21},"2025-12",{"name":47,"class":48},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":514,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":161},"100527679","phase-2-ketorolac-and-pregabalin-effects-on-breast-cancer-keprest-100527679","NCT06150898","Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)","Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity","KePreSt","Inclusion Criteria:\n\nSubjects must meet all of the following criteria in order to be eligible for this study:\n\n1. Age ≥ 18 years and ≤ 70 years old\n2. Female\n3. Weight ≥ 35 kg\n4. Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and\u002For Allred score of 3 or more\n5. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI\u002FCT scan.\n6. Stage I, II or III disease (non-metastatic)\n7. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing\n8. Subject scheduled for a primary breast cancer surgery\n9. Subject is willing to provide plasma\u002Fblood and tumour samples for translational research.\n10. Subject is willing to provide tissue from a newly obtained core or excisional biopsy of the tumour that should be evaluable for central histological characterization and future molecular testing\n11. Subject is willing to take omeprazole and has no contraindication to omeprazole.\n12. Have an HEMSTOP score\\\u003C2 and conventional coagulation screening test within normal limits such as activated partial thromboplastin time (21.6\\\u003C aPTT \\>28.7), international normalised ratio (1.31\\\u003CINR) and platelet count (\\>100.10³\u002Fml)\n13. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least one months after the last administration of study treatment.\n14. Negative serum pregnancy test for women of childbearing potential (within 30 days before start of treatment)\n15. Subject is willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\nSubjects meeting one of the following criteria are not eligible for this study:\n\n1. Subject planned for intraoperative radiotherapy\n2. Subject planned for immediate reconstruction\n3. Neoadjuvant BC therapy\n4. Allergy to any NSAID or gabapentinoïd\n5. Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications. Hypersensitive to peanut or soya (related to propofol contraindications)\n6. Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy.\n7. Current NSAID (\\> twice a week the year prior to diagnosis) or pregabalin use\n8. Previous malignant pathology within 5 years prior to inclusion or currently undergoing maintenance therapy. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer.\n9. Active or history of peptic ulcer disease or gastro-intestinal bleeding or perforation\n10. Pregnancy or lactating women\n11. Chronic inflammatory disease as rheumatoid arthritis, uncontrolled asthma, chronic heart failure, chronic obstructive pulmonary disease, cystic fibrosis, inflammatory myopathies (e.g., idiopathic polymyositis, dermatomyositis, inclusion body myositis), inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), McArdle's disease, multiple sclerosis, lupus, chronic inflammatory demyelinating polyneuropathy, psoriasis, autoimmune thyroiditis as Graves' disease or Hashimoto's thyroiditis (unless previous surgical ablation), myasthenia gravis, vasculitis.\n12. Complete or partial nasal polyposis syndrome, Quincke's oedema, bronchospasm, asthma\n13. Known chronic infectious disease as active hepatitis B (defined as positive serology for Ac anti-HBc and IgM anti HBc OR Ac anti HBc and Ag HBs), active hepatitis C (defined as positive serology for anti-VHC and positive PCR-VHC) or active tuberculosis (included under treatment)\n14. Uncontrolled HIV infection (defined as detectable viral loads by standard clinical assays) or controlled HIV infection (defined undetectable HIV viral loads by standard clinical assays) treated by one of following drugs: Nelfinavir, Atazanavir or Saquinavir (related to interaction with omeprazole).\n15. Infection currently treated with one of the following drugs: posaconazole, voriconazole, ketoconazole and rifampicin, unless discontinuation of treatment is planned at least 10 days prior to the start of study treatment AND with complete resolution according to expert opinion (related to interaction with omeprazole)\n16. Inadequate liver function (defined as total serum bilirubin ≥ 2 x upper limit of normal (ULN\\\u003C1.2 mg\u002Fdl) - unless documented Gilbert syndrome- AND Alanine Aminotransferase (ALT) ≥ 2 x ULN (ULN \\\u003C32 UI\u002Fl and ULN \\\u003C33 UI\u002Fl, respectively) AND Alkaline phosphatase (ALP) ≥ 2.5 x ULN (ULN=104 UI\u002Fl))\n17. Cirrhosis or severe hepatitis.\n18. Renal impairment (defined as GFR\\\u003C90ml\u002Fmin\u002F1.73m² or serum creatinine \\> 442 μmol\u002Fl or \\> 5 mg\u002FdL) or single kidney or previous renal surgery\n19. Subject with history of (severe) renal toxicity with an NSAID\n20. Subject with a recent history of operations associated with a high risk of bleeding\n21. Previous, ongoing or suspected cardiovascular disease defined as history of ischemic heart disease or heart failure or uncontrolled high blood pressure (Systolic ≥160mmHg and\u002For diastolic ≥100mmHg) or peripheral arterial disease or cerebrovascular disease\n22. Subject with a recent history of surgery associated with a high risk of bleeding\n23. Hemostasis disorder as haemophilia, Von Willebrand disease, constitutional thrombopathies or thrombocytopenia (defined as platelet count \\\u003C 100 000\u002Fmm³), current \u002Fplanned anticoagulant or anti-platelet therapy.\n24. Inadequate bone marrow function (defined as absolute neutrophil count \\\u003C1000\u002FμL and platelet count \\\u003C100'000\u002FμL)\n25. Systemic immunosuppressive treatment (defined as systemic corticotherapy or anti-rejection treatment or interferon therapy) within the 2-years prior diagnosis\n26. Psychiatric disease or antipsychotic\u002F antidepressant use\n27. Epilepsy or any current anti-epileptic drug use\n28. Obstructive sleep apnea\n29. ASA≥3",{"count":508,"type":21},112,[24],"Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer.\n\nTo contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug.\n\nOur goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and\u002For eliminating residual disease using repurposing drugs",[512,513],"Early-stage Breast Cancer","Estrogen-receptor-positive Breast Cancer",[515,516,517,518,519,520,521,522,523],"Surgery","Inflammation","Breast cancer","Neuronal features","Ketorolac","Pregabalin","Adiposity","Neurotransmitter","Nerves","2025-06-10",{"date":526,"type":41},"2025-06-13",{"date":528,"type":41},"2025-05-12",{"date":530,"type":21},"2027-10",{"name":47,"class":48},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":241,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":547,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":161},"100582767","the-added-value-of-psma-pet-in-detecting-clinically-significant-prostate-cancer-lesions-in-patients-undergoing-mri-targeted-biopsy-pandora-100582767","NCT06867588","The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA)","The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA): a Prospective, Paired Diagnostic Study","PANDORA","Inclusion Criteria:\n\nSubjects must meet the following criteria for inclusion in the study:\n\n* Men ≥ 18 years of age\n* Multiparametric MRI within the previous 6 months\n* At least one lesion PI-RADS 3\n* Able to provide written informed consent\n\nExclusion Criteria:\n\nEligible subjects must not meet any of the exclusion criteria listed below:\n\n* Previous prostate cancer diagnostic on MRI-targeted biopsy\n* At least one lesion PI-RADS 4-5\n* Negative MRI (PI-RADS 1-2)\n* Previous treatment for prostate cancer 11\n* Contraindication to PSMA PET and\u002For MRI and\u002For prostate biopsy\n* Low quality of MRI defined by a PI-QUAL score of 1 or 2\n* Any medical condition that may interfere with the study procedures.",{"count":541,"type":21},68,[89],"Prostate Specific Membrane Antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. Indeed, several studies have shown that PSMA PET\u002FCT outperformed choline PET\u002FCT with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low PSA level. Moreover, the proPSMA trial reported that PSMA PET\u002FCT had 27% greater accuracy than that of CT and bone scanning when staging patients with high-risk localised prostate cancer. More recently, availability of integrated PET\u002FMRI scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. It also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions.\n\nIn the light of current issues, the next question is whether PSMA PET imaging could add to the detection of prostate cancer. Several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic PSMA PET\u002FCT . Recently, in the PRIMARY trial, 291 men received successively MRI, PSMA PET\u002FCT and systematic ± MRI-targeted biopsies. Despite similar PPV between imaging methods, the main advantage of PSMA was in men with equivocal MRI. Indeed, they found that 90% of csPCa was identified by PSMA PET\u002FCT in this subgroup and paved the way for further investigation. This finding was confirmed in the most recent systematic review and meta-analysis.\n\nThe aim of this prospective study is to evaluate the added-value of PSMA PET in detecting prostate cancer in patients who are candidates for biopsy with equivocal MRI.",[545,546],"Multiparametric MRI","Lesion PI-RADS 3",[548,549],"PSMA PET","MRI-targeted biopsy","2025-03-26",{"date":552,"type":41},"2025-03-31",{"date":554,"type":41},"2024-10-17",{"date":556,"type":21},"2026-12",{"name":47,"class":48},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":161},"100524352","molecular-imaging-of-fap-expressing-cancer-associated-fibroblasts-in-nsclc-treated-with-immune-checkpoint-inhibitors-100524352","NCT06107608","Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors","LIFE","Inclusion Criteria:\n\n* Age above 18 years.\n* Pathologically- proven non-small-cell lung cancer (NSCLC).\n* Proposed for treatment with anti-PD-(L)1 alone or in combination with chemotherapy and\u002For anti-CTLA4 in the advanced setting.\n* ECOG Performance status ≤2.\n* Patient's written informed consent obtained prior to any study procedure.\n\nExclusion Criteria:\n\n* Surgery and\u002For radiotherapy to thoracic region within the last 8 weeks or anti-cancer systemic therapy within the last 2 weeks.\n* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and c-ros oncogene (ROS1) mutations.\n* Pregnant and lactating women\n* Previous or concurrent malignancy diagnosed within the last 2 years except adequately treated in situ carcinoma of the cervix uteri, localised (T1N0) low grade (Gleason score 6) prostate cancer undergoing active surveillance and basal or squamous cell skin cancer.\n* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.",{"count":566,"type":21},58,[89],"Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent\u002Fmetastatic disease.",[570],"Non Small Cell Lung Cancer",[572,573,570,574,575,576,577],"Immunotherapy","FAPI-46","PET","PET\u002FCT","fibroblast activation protein","fibroblast activation protein inhibitor",{"date":552,"type":41},{"date":580,"type":41},"2023-06-13",{"date":582,"type":21},"2027-12-01",{"name":47,"class":48},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":161},"100520846","ga68-fapi-46-petct-for-preoperative-assessment-of-peritoneal-carcinomatosis-100520846","NCT06061874","Ga68-FAPI-46 PET\u002FCT for Preoperative Assessment of Peritoneal Carcinomatosis","Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET\u002FCT for Preoperative Assessment of Peritoneal Carcinomatosis","FAPeCa","Inclusion Criteria:\n\n* Histologically proven colorectal and ovarian cancer.\n* Known or suspected peritoneal metastases from the tumour of origin.\n* Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.\n* ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.\n* Signed written informed consent obtained before any study-specific screening procedures.\n\nExclusion Criteria:\n\n* Non-resectable extra-abdominal metastasis and\u002For \\>3 hepatic metastases on standard work-up\n* Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)\n* Pregnant and lactating women\n* Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.\n* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.",{"count":593,"type":21},80,[89],"This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET\u002FCT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).\n\nThe aim of the study is to assess the accuracy of Ga68-FAPI-46 PET\u002FCT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.",[597,330],"Cancer",[599,600,601,577,602,573,574,603,575,576],"colorectal cancer","ovarian cancer","peritoneal carcinomatosis","positron emission tomography","FAPI",{"date":552,"type":41},{"date":606,"type":41},"2023-05-30",{"date":497,"type":21},{"name":47,"class":48},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":615,"enrollmentInfo":616,"targetDuration":618,"studyType":204,"phases":4,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":4},"100537875","evaluation-of-the-restart-survival-programme-100537875","NCT06283511","Evaluation of the RESTART Survival Programme","Inclusion Criteria:\n\n1. Age \\>= 18 at the time of signing the ICF\n2. Minimum understanding of French\n3. Signed study informed consent form obtained prior to any study-related procedure.\n4. Participation in the RESTART programme\n5. Patient with curative breast cancer (AJCC stage I-II-III)\n\nExclusion Criteria:\n\n\\-","99 Years",{"count":617,"type":21},200,"15 Months","The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.",[621],"Invasive Breast Cancer","2025-02-25",{"date":624,"type":41},"2025-02-28",{"date":626,"type":21},"2025-03-01",{"date":556,"type":21},{"name":47,"class":48},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":161},"100533555","icg-fluorescence-imaging-for-intraoperative-breast-cancer-margins-evaluation-a-dose-timing-study-100533555","NCT06227338","ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study","BREASTIFLU-1","Inclusion Criteria:\n\n1. female;\n2. age of ≥18 years;\n3. histological diagnosis of ductal invasive breast cancer;\n4. a primary early-stage invasive breast cancer (cT1 and\u002For cT2, assessed clinically and\u002For radiologically), without prior BC surgery of the actually affected breast;\n5. ECOG Performance Status (PS) 0 or 1;\n6. signed informed consent form (ICF) obtained prior to any study related procedure.\n\nExclusion Criteria:\n\n1. advanced invasive breast cancer (cT3 and\u002For cT4);\n2. in situ breast cancer disease;\n3. lobular invasive breast cancer (at histology);\n4. invasive breast cancer treated by neoadjuvant chemotherapy and\u002For endocrine therapy;\n5. prior history of invasive or breast cancer of the actually affected breast in the past;\n6. history of allergy or hypersensitivity to investigational product (active substance or ingredients);\n7. history of allergy to iodine or to shellfish;\n8. have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;\n9. documented coronary disease\n10. advanced renal insufficiency (serum creatinine \\>1.5 mg\u002FdL);\n11. chronic liver disease with the Child-Pugh class B or C ;\n12. concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation;\n13. pregnant or lactating women;\n14. inability to give informed consent.",{"count":637,"type":21},250,[89],"Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.\n\nTwo preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.\n\nIn the first time frame (intraoperative arms), the dose of, respectively 0.125 mg\u002Fkg and 0.25 mg\u002Fkg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.\n\nIn the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg\u002Fkg, 1 mg\u002Fkg, and 2 mg\u002Fkg of ICG will be administered 24 h before surgery in 3 subgroups.",[207],[517,642,643],"Conservative surgery","Indocyanine Green",{"date":645,"type":41},"2025-02-26",{"date":647,"type":41},"2024-02-12",{"date":649,"type":21},"2026-01-01",{"name":47,"class":48},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":662,"conditions":663,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":671,"locationsCount":672},"100364002","phase-3-assessment-of-swallowing-function-and-quality-of-life-in-oropharyngeal-cancer-patients-treated-by-chemo-radiotherapy-100364002","NCT04019548","Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy","Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy","SwallPEG","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. ECOG performance status ≤ 2\n3. Female and Male\n4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx\n5. Candidate for curative intent radiotherapy and systemic treatment\n6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)\n7. Diagnosis biopsy results\n8. HPV\u002Fp 16 testing results\n9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.\n10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.\n11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.\n12. Adequate bone marrow function as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1500\u002FµL or 1.5x109\u002FL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Platelets ≥100000\u002FµL or 100x109\u002FL\n13. Adequate liver function as defined below:\n\n    * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \\\u003C 3 x UNL is allowed\n    * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n14. Adequate renal function as defined below:\n\n    * Creatinine ≤ 1.5 x UNL and creatinine clearance \\> 60 mL\u002Fmin\n15. Peripheral neuropathy ≤ grade 1\n16. Hear impaired ≤ grade 1\n17. Completion of all necessary screening procedures within 15 days prior to randomisation.\n18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening\n\nExclusion Criteria:\n\n1. Severe malnutrition\n2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\\_v.5)\n3. Distant metastasis\n4. Serious coagulation disorders (INR\\>1.5, PTT\\>50s, platelets \\\u003C50000\u002Fmm3)\n5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal\u002Fsquamous cell carcinoma of the skin;\n7. Pregnant and\u002For lactating women.\n8. Known hypersensitivity to the study drug (cisplatin) or excipients.",{"count":396,"type":21},[661],"PHASE3","Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.\n\nStudy is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.\n\nAll subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).",[664],"Oropharyngeal Cancer","2023-05-09",{"date":667,"type":41},"2023-05-10",{"date":669,"type":41},"2019-12-16",{"date":385,"type":21},{"name":47,"class":48},2,""]