[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alexander Valdman\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100554589","contact-radiotherapy-for-rectal-cancer-100554589",false,"NCT06501053","Contact Radiotherapy for Rectal Cancer","Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial","CORRECT","Inclusion Criteria:\n\n* Adenocarcinoma of the rectum classified as:\n* cT1-cT3ab, \\\u003C 5 cm largest diameter and \\\u003C ½ circumference (MRI staging), N0-N1 (\\\u003C= 3 nodes \\\u003C 8mm diameter), M0\n* Performance status (ECOG) 0-1\n* Operable patient\n* Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm\n* 18 years or above\n* No comorbidity preventing treatment\n* Patient having read the information note and having signed the informed consent\n* Follow-up possible\n\nExclusion Criteria:\n\n* Inoperable patient\n* T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference\n* Distance from the lower tumor border to the anal verge \\>10 cm\n* N2-status at diagnosis or N1 with any node\\>= 8 mm diameter\n* Patient presenting with metastasis at diagnosis (M1)\n* Previous pelvic irradiation\n* Tumor with extramural vascular invasion\n* Poorly differentiated tumor\n* Simultaneous progressive cancer\n* Tumor invading external anal sphincter or growth within 1 mm of the levator\n* Tumor within 1 mm from MRF (mesorectal fascia)\n* Patient unable to receive CXB or CRT\n* Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy\n* Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol\n* Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment\n* Total DPD deficiency","ALL","18 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).",[27],"Rectal Cancer",[29,30,31,32],"organ sparing","brachytherapy","radiotherapy","nonoperative","RECRUITING","2026-08-06",{"date":36,"type":37},"2026-08-10","ACTUAL",{"date":39,"type":37},"2025-03-03",{"date":41,"type":21},"2032-11",{"name":43,"class":44},"Alexander Valdman","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100402876","preoperative-short-course-radiation-therapy-with-protons-compared-to-photons-in-high-risk-rectal-cancer-prorect-100402876","NCT04525989","Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)","Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT): A Prospective Randomized Swedish Phase II Trial","PRORECT","Inclusion Criteria:\n\nInclusion Criteria - Primary tumour characteristics\n\n* Biopsy-proven, newly diagnosed primary rectal adenocarcinoma, i.e. with the lowest part of the tumour less than 16 cm from the anal verge detected using a rigid rectoscope.\n* Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and\u002For systemically:\n\n  * Clinical stage (c) T4b, i.e. infiltration of an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side-wall (according to TNM version 8).\n  * cT4a, i.e. peritoneal involvement.\n  * Extramural vascular invasion (EMVI+).\n  * N2-status regarded as metastatic according to ESGAR consensus criteria\n  * Positive MRF, i.e. tumor or lymph node one mm or less from the mesorectal fascia.\n  * Metastatic lateral nodes (lat LN+) according to ESGAR consensus criteria\n\nInclusion Criteria - General\n\n* Staging done within 6 weeks before start of radiotherapy. No contraindications to chemotherapy with CAPOX including adequate blood counts, (within 5 weeks prior to randomisation):\n\n  * white blood count ≥4.0 x 10\\*9\u002FL\n  * platelet count ≥100 x 10\\*9\u002FL\n  * clinically acceptable haemoglobin levels\n  * creatinine levels indicating renal clearance of ≥50 ml\u002Fmin\n  * bilirubin ˂35 µmol\u002Fl.\n* ECOG performance score ≤1\n* Patient is considered to be mentally and physically fit for chemotherapy with CAPOX as judged by the oncologist.\n* Age ≥18 years\n* Written informed consent.\n* Adequate potential for follow-up.\n\nExclusion Criteria:\n\n* Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen.\n* Presence of metastatic disease or recurrent rectal tumour. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis.\n* Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.\n* Known DPD deficiency.\n* Any contraindications to MRI (e.g. patients with pacemakers).\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.\n* Concurrent uncontrolled medical conditions.\n* Any investigational treatment for rectal cancer within the past month.\n* Pregnancy or breast feeding.\n* Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract.\n* Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months.\n* Patients with symptoms of peripheral neuropathy.\n* Patients with pacemaker or ICD\n* Patients with bilateral hip protheses",{"count":54,"type":21},254,[24],"To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.",[27],[59,60,61,62],"Proton therapy","Preoperative radiation","Short-course","Primary adenocarcinoma",{"date":36,"type":37},{"date":65,"type":37},"2021-04-20",{"date":67,"type":21},"2028-03",{"name":43,"class":44},9,""]