[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-fallopian-tube-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-fallopian-tube-cancer-ajcc-v8":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,112,146,181],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100446356","phase-1-phase-i-study-of-tumor-treating-fields-ttf-in-combination-with-cabozantinib-or-with-pembrolizumab-and-nab-paclitaxel-in-patients-with-advanced-solid-tumors-involving-the-abdomen-or-thorax-100446356",false,"NCT05092373","Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax","Inclusion Criteria:\n\n* Participants must have pathologically confirmed advanced\u002Fmetastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian\u002Ffallopian, or endometrial\u002Fprimary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.\n* Age: ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\>3 months.\n* Normal bone marrow function, defined as absolute neutrophil count ≥1,000\u002FµL; platelets ≥75,000\u002FµL; hemoglobin ≥8 g\u002FdL.\n* Adequate hepatic function as defined by a total bilirubin level ≤1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's syndrome, and alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤2.5 x ULN (unless the patient has liver metastases: ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤5 x ULN).\n* Participants with HCC must have a Child Pugh status A, no clinically significant ascites (requiring pharmacological or interventional treatment), and no history (or increased risk) of esophageal\u002Fgastric bleeding, impaired wound healing, perforation or fistula.\n* Serum creatinine clearance ≥50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Measurable disease by RECIST or evaluable disease.\n* Contraception: Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Male participants must agree to use effective contraception or abstinence while on study.\n* Able to operate the TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n* Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.\n* Participants must have recovered to Grade 0-1 toxicity from prior therapy.\n* Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.\n* The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure \\[BP\\] \\> 160\u002F100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).\n* The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n* Concurrent malignancies are permitted if (A) they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or (B) with agreement from the Principal Investigator (PI), participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or (C) with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n* The patient is pregnant or breastfeeding.\n* History of hypersensitivity or contraindication to TTF.\n* Implanted pacemaker, defibrillator or other electrical medical devices.\n* The participant has a previously-identified allergy or hypersensitivity to cabozantinib, nab-paclitaxel, or pembrolizumab, medical adhesives or hydrogel or the patient has received prior cabozantinib and discontinued therapy due to unacceptable toxicity.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n* CABOZANTINIB COHORT ONLY: The patient has experienced clinically-significant hematemesis or hemoptysis of \\> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel.\n* CABOZANTINIB COHORT ONLY: The patient has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) test results that are above (1.3X) the laboratory upper limit of normal.\n* CABOZANTINIB COHORT ONLY: The subject has a corrected QT interval (QTcF) \\> 450 ms for men or \\> 470 ms for women.\n* CABOZANTINIB COHORT ONLY: The patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents. Low-dose aspirin (≤ 81 mg\u002Fday), low dose warfarin (≤ 1mg\u002Fday), and prophylactic low molecular weight heparin (LMWH) are permitted.\n* CABOZANTINIB COHORT ONLY: Patients with encasement of a major artery or bowel by tumor are excluded.\n* CABOZANTINIB COHORT ONLY: The patient is unable to swallow capsules.\n* CABOZANTINIB COHORT ONLY: History of hypersensitivity or contraindication to cabozantinib.\n* ATEZOLIZUMAB-CONTAINING COHORT: Participants who have received prior immunotherapy, including prior anti-PD-1 or anti-PD-L1 therapies may participate: (A) only if their prior anti-PD-1 or anti-PDL1 monotherapy or combination therapy were NOT the last treatment prior to participation on this study. (B) Participants who had prior immunotherapies and experienced Grade 1-2 immune-related adverse event (irAE) must have documentation that their irAEs are Grade 1 or 0 using current Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and participants must be off steroid therapy and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 14 days from Cycle 1, Day 1. (C) Participants who experienced Grade 3 irAEs consisting of laboratory abnormalities that were asymptomatic and have now resolved to Grade 1 or 0 and participants who have been off steroid and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 30 days from Cycle 1, Day 1. Participants with prior irAE pneumonitis (\\>= Grade 2) should not be given atezolizumab.\n* ATEZOLIZUMAB-CONTAINING COHORT: Human immunodeficiency virus (HIV) infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics.\n* ATEZOLIZUMAB-CONTAINING COHORT: Has received a live vaccine within 30 days prior to first dose.\n* ATEZOLIZUMAB-CONTAINING COHORT: Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.\n* ATEZOLIZUMAB-CONTAINING COHORT: Serious autoimmune disease at the discretion of the treating attending: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g. Wegener's Granulomatosis) are excluded from this study.\n* ATEZOLIZUMAB-CONTAINING COHORT: History of\u002For current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.","ALL","18 Years",{"count":18,"type":19},43,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Advanced Breast Carcinoma","Advanced Endometrial Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Malignant Abdominal Neoplasm","Advanced Malignant Female Reproductive System Neoplasm","Advanced Malignant Thoracic Neoplasm","Advanced Ovarian Carcinoma","Advanced Primary Peritoneal Carcinoma","Advanced Renal Cell Carcinoma","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Abdominal Neoplasm","Malignant Solid Neoplasm","Metastatic Breast Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Fallopian Tube Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Abdominal Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Metastatic Malignant Thoracic Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Primary Peritoneal Carcinoma","Metastatic Renal Cell Carcinoma","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage III Fallopian Tube Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Fallopian Tube Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Primary Peritoneal Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Fallopian Tube Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Fallopian Tube Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Fallopian Tube Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Primary Peritoneal Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Fallopian Tube Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Primary Peritoneal Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","RECRUITING","2026-07-15",{"date":102,"type":103},"2026-07-16","ACTUAL",{"date":105,"type":103},"2022-04-29",{"date":107,"type":19},"2026-09-01",{"name":109,"class":110},"M.D. Anderson Cancer Center","OTHER",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":20,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100360076","phase-1-talazoparib-and-radiation-therapy-in-treating-patients-with-locally-recurrent-gynecologic-cancers-100360076","NCT03968406","Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers","Phase I Study of Talazoparib in Combination With Radiation Therapy for Locally Recurrent Gynecologic Cancers","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis\n* Subjects with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy \\[RT\\]) is undetectable or stable (\\>= 3 months) and immediate chemotherapy is not required. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks prior to start of investigational therapy\n* Hemoglobin \\>= 10.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\u002Frandomization (choose whichever is most applicable to the study) (within 28 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear (within 28 days prior to administration of study treatment)\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Platelet count \\>= 100 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be =\\\u003C 5 x ULN (within 28 days prior to administration of study treatment)\n* Serum creatinine =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\n  * Note: If cannot fulfill ECOG 0-1, must fulfill inclusion criteria below (minimum life expectancy of \\>= 16 weeks)\n* Patients must have a life expectancy \\>= 16 weeks\n* Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50, radiation-induced oophorectomy with last menses \\> 1 year ago, chemotherapy-induced menopause with \\> 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Patient of child-bearing potential is willing to adhere to using two forms of highly effective birth control. Condoms with spermicide and one of the following are acceptable: oral contraceptive or hormonal therapy or placement of an intrauterine device (IUD). Acceptable non-hormonal birth control methods include: total sexual abstinence, vasectomized sexual partner plus male condom, tubal occlusion plus male condom with spermicide, IUD plus male condom+spermicide. Acceptable hormonal methods include: etonogestrel implants (i.e. Implanon, Norplan), normal and low dose combined oral pills, norelgestromin\u002Fethinyl estradiol (EE) transdermal system, intravaginal device (i.e. EE and etonogestrel) or cerazette (desogestrel). All of these would need to be combined with male condom with spermicide\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* At least one lesion, not previously irradiated, that can be accurately measured at baseline as \\>= 10 mm in the longest diameter (except lymph nodes which must have short axis \\>= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements\n* For inclusion in biomarker endpoint, patients must fulfill the following criterion:\n\n  * Provision of informed consent for tumor biopsies \\* If a patient declines to participate in tumor biopsies, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to that part\n\nExclusion Criteria:\n\n* Ascites, peritoneal carcinomatosis, hepatic metastases\n* Prior radiotherapy in the region of planned radiotherapy\n* Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy\n* Previous enrollment in the present study\n* Participation in another clinical study with an investigational product during the last 4 weeks\n* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \\>= 5 years (will require discussion with study physician)\n* Patients receiving any systemic chemotherapy, radiotherapy\n* Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir\n* Concomitant use of known P-gp inhibitors (i.e. dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-glycoprotein (P-gp) inducers (i.e. rifampin, tipranavir, ritonavir), or breast cancer resistance protein (BCRP) inhibitors (i.e. elacridar \\[GF120918\\]) should be avoided. If patients are taking any P-gp inhibitors, P-gp inducers, or BRCP inhibitors, they will need to stop them prior to enrolment on the study\n* Persistent toxicities (\\>= Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade 2) with the exception of alopecia, caused by previous cancer therapy\n* Resting electrocardiogram (ECG) with corrected QT (QTc) \\> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment\n* Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (CT) scan or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Breast feeding women\n* Patients with a known hypersensitivity to talazoparib or any of the excipients of the product\n* Patients with uncontrolled seizures\n* Patients requiring pelvic and para-aortic radiotherapy (defined as levels L1\u002FT12)\n* Patients with isolated vaginal relapse (i.e. no disease in lymph nodes or else where in pelvis\u002Fabdomen)",{"count":120,"type":19},24,[22],"This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.",[124,125,126,127,128,129,130,131,83,85,86,88,132,133,89,91,92,93,134,135,94,96,97,98,136],"Malignant Female Reproductive System Neoplasm","Recurrent Cervical Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Vaginal Carcinoma","Stage IV Cervical Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Vaginal Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Vaginal Cancer AJCC v8","2026-03-10",{"date":139,"type":103},"2026-03-11",{"date":141,"type":103},"2019-09-26",{"date":143,"type":19},"2027-10-01",{"name":109,"class":110},2,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":153,"minAge":16,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":20,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100406708","phase-3-minimally-invasive-surgery-after-neoadjuvant-chemotherapy-for-the-treatment-of-stage-iiic-iv-ovarian-primary-peritoneal-or-fallopian-tube-cancer-lance-trial-100406708","NCT04575935","Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial","Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma or pathology consistent with high-grade mullerian carcinoma.\n* Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity. Pleural effusions are acceptable per the local PI's discretion.\n* Normalization of CA-125 according to individual participating center reference range (Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot exceed 35 U\u002FmL at the completion of NACT prior to interval debulking surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or laparotomy.\n* Timeframe of \\\u003C 6 weeks (42 days) from the last cycle of NACT to interval debulking surgery. Overall timeframe may be extended per MD Anderson PI discretion.\n* ECOG performance status 0-2\n* Signed informed consent and ability to comply with follow-up\n* Negative pregnancy test by blood or urine (within 14 days prior to surgery)\n* Disease free of other active malignancies in the previous five years, except basal and squamous cell carcinomas of the skin\n\nExclusion Criteria:\n\n* Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the following findings that may preclude minimally invasive resection per surgeon's assessment. • Failure of improvement of ascites during NACT (trace ascites is allowed) • Small bowel or gastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumor involvement • Splenic or hepatic surface or parenchymal tumor involvement • Mesenteric tumor involvement • Tumor infiltration of the lesser peritoneal sac\n* History of psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule\n* Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed by participating institution's clinicians\n* Any other contraindication to MIS as assessed by the clinician","FEMALE",{"count":155,"type":19},580,[157],"PHASE3","This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and\u002For improving quality of life after surgery.",[32,160,161,162,163,164,165,166,167,168,169,170,171,77,78,79,83,85,86,89,91,92,94,96,97],"Fallopian Tube Clear Cell Adenocarcinoma","Fallopian Tube Endometrioid Tumor","Fallopian Tube Serous Neoplasm","Fallopian Tube Transitional Cell Carcinoma","Ovarian Clear Cell Adenocarcinoma","Ovarian Endometrioid Adenocarcinoma","Ovarian Serous Adenocarcinoma","Ovarian Transitional Cell Carcinoma","Primary Peritoneal Clear Cell Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal Serous Adenocarcinoma","Primary Peritoneal Transitional Cell Carcinoma","2026-03-03",{"date":174,"type":103},"2026-03-05",{"date":176,"type":103},"2020-08-05",{"date":178,"type":19},"2028-12-31",{"name":109,"class":110},19,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":20,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":111},"100581853","an-automated-personalized-physical-activity-intervention-to-improve-immune-function-and-clinical-outcomes-in-stage-ii-iv-ovarian-primary-peritoneal-or-fallopian-tube-cancer-and-newly-diagnosed-endometrial-cancer-life-on-the-go-3-study-100581853","NCT06855706","An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study","Life on the Go 3: A Randomized Controlled Trial of Automated, Personalized Physical Activity Intervention Using Wearable Devices to Improve Immune Function and Clinical Outcomes in Ovarian and Endometrial Cancer Patients","Inclusion Criteria:\n\n* Age ≥ 18 years old on day of signing informed consent\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participant must satisfy one of the following conditions:\n\n  * Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery\n  * Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis\n  * Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management\n* willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours\u002Fday) throughout the 6-month study period\n* under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following:\n\n  * Receiving cancer treatment at Roswell Park Comprehensive Cancer Center\n  * Undergoing surgery at Roswell Park Comprehensive Cancer Center\n  * Participating in surveillance visits at Roswell Park Comprehensive Cancer Center\n  * Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers\n* willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n* Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications)\n\n  * NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function\n\nExclusion Criteria:\n\n* serious psychiatric illness that is not currently stabilized, including but not limited to:\n\n  * Schizophrenia or other psychotic disorders\n  * Bipolar disorder\n  * Sever major depressive disorder\n  * Severe personality disorders diagnosed by a qualified mental health professional\n  * Recent suicide attempt or psychiatric hospitalization within the previous 12 months\n* Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools\n* history of other invasive malignancies within the last two years, except for:\n\n  * Non-melanoma skin cancer\n  * In situ cervical cancer\n* resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements\n* systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements\n* Unstable angina or myocardial infarction within the past 3 months.\n\n  * Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention\n  * Myocardial Infarction: Heart attack diagnosed by a medical professional\n* Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures.\n* unwilling or unable to follow the protocol requirements, including but not limited to:\n\n  * Cognitive impairment that affects the ability to provide informed consent or comply with study procedures\n  * Language barriers without access to adequate translation services\n  * Lack of access to necessary technology (e.g., smartphones compatible with study devices)\n  * Other factors that would prevent adherence to study protocols\n* Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to:\n\n  * Severe pulmonary disease\n  * Uncontrolled metabolic disorders\n  * Other significant medical conditions that pose a risk during increased physical activity\n* Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.",{"count":189,"type":19},120,[191],"NA","This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.",[194,127,128,129,195,196,197,57,59,60,83,85,86],"Endometrial Carcinoma","Stage II Fallopian Tube Cancer AJCC v8","Stage II Ovarian Cancer AJCC v8","Stage II Primary Peritoneal Cancer AJCC v8","2026-01-02",{"date":200,"type":103},"2026-01-06",{"date":202,"type":103},"2025-06-04",{"date":204,"type":19},"2028-04-30",{"name":206,"class":110},"Roswell Park Cancer Institute"]