[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618919":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":32,"overallOfficials":18,"centralContacts":38,"locations":44,"responsibleParty":59,"collaborators":18,"id":63,"slug":18,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Two year TME-free survival","Patients alive and without TME-surgery","Two years from the start of radiotherapy",[14],{"measure":15,"description":16,"timeFrame":17},"Clincal complete response rate","Patients who have no evidence of residual tumor on MRI and rectoscopy","three months after the end of radiotherapy",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"MR guided dose escalated radiotherapy","EXPERIMENTAL","A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes.",[31],"Radiation: Dose escalated radiotherapy using a 1.5 T MR-Linac",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":18},"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",[27],[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Cihan Gani, MD","CONTACT","+4970712982165","cihan.gani@med.uni-tuebingen.de",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":18},"University Hospital Tübingen","RECRUITING","Tübingen","Baden-Wurttemberg","72074","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],9.05222,48.52266,{"lat":57,"lon":56},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. Cihan Gani","Prof.","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":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79],"Rectal Cancer",[81],"organ preservation","2026-02-14",{"date":84,"type":85},"2026-02-17","ACTUAL",{"date":87,"type":85},"2026-01-07",{"date":89,"type":73},"2029-01",{"name":5,"class":6},1]