[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618919":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MR guided dose escalated radiotherapy","EXPERIMENTAL","A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes.",[13],"Radiation: Dose escalated radiotherapy using a 1.5 T MR-Linac",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Dose escalated radiotherapy using a 1.5 T MR-Linac","Dose escalated radiotherapy using a 1.5 T MR-Linac is given to the primary tumor and affected lymph nodes in an online adaptive manner",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Cihan Gani, MD","CONTACT","+4970712982165","cihan.gani@med.uni-tuebingen.de",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"University Hospital Tübingen","RECRUITING","Tübingen","Baden-Wurttemberg","72074","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],9.05222,48.52266,{"lat":40,"lon":39},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Dr. Cihan Gani","Prof.","100618919","phase-2-organ-preservation-in-rectal-cancer-by-dose-escalated-mr-guided-adaptive-radiotherapy-100618919",false,"NCT07337876","Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy","MARS","Inclusion Criteria:\n\n* Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line\n* Any MRI staged rectal cancer meeting the following criteria\n* cT1-cT3 and\n* cN0 -cN1 and\n* cM0\n* Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep anastomosis with expected poor organ function.\n* Tumor affects less than 70% of the rectal circumference.\n* Maximum longitudinal extension of the tumor less than 8 cm on MRI\n* MR-Staging requirements: High-resolution, thin-sliced (i.e.\n\n  ≤3mm) magnetic resonance imaging (MRI) of the pelvis.\n* Cross-sectional imaging of the abdomen and chest to exclude distant metastases.\n* Aged at least 18 years. No upper age limit.\n* WHO\u002FECOG Performance Status ≤ 1\n* Adequate hematological, hepatic, renal and metabolic function parameters\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy\n* Distant metastases\n* Preexisting fecal incontinence for solid stool\n* Prior antineoplastic therapy for rectal cancer\n* Prior radiotherapy of the pelvic region\n* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.\n* Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).\n* Other concomitant antineoplastic therapy\n* Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active,uncontrolled infections, active, disseminated coagulation disorder\n* Other primary tumors with an estimated life expectancy of less than three years\n* Contraindications for treatment with 5-Fluorouracil or Capecitabine\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).","ALL","18 Years",{"count":56,"type":57},100,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.",[63],"Rectal Cancer",[65],"organ preservation","2026-02-14",{"date":68,"type":69},"2026-02-17","ACTUAL",{"date":71,"type":69},"2026-01-07",{"date":73,"type":57},"2029-01",{"name":5,"class":6},1]