[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572159":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":91,"collaborators":19,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":19,"enrollmentInfo":105,"targetDuration":19,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":19,"overallStatus":114,"whyStopped":19,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University Hospital of Cologne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Rectal cancer","EXPERIMENTAL","Patients will be initially treated with EBRT with 13 x 3 Gy to a total dose of 39 Gy to the primary tumor and pelvic lymph node, over a period of 2.5 weeks. Restaging with pelvic MRI and endoscopy will then be performed 6.5 weeks after completion of EBRT and prior to the first endorectal HDR-BT fraction to evaluate initial therapy response and the residual extent of the disease for target outlining. Following that, endorectal HDR-BT will be delivered with 3 x 8 Gy to a total dose of 24 Gy (dose prescription: 5 mm depth for cT1 tumors; 10 mm depth for cT2-3 tumors), with each endorectal brachytherapy application performed once weekly.",[13],"Other: radiotherapy",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"radiotherapy","External beam radiotherapy and endorectal brachytherapy",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Emmanouil Fokas, MD DPhil","STUDY_CHAIR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+49 22147898710","emmanouil.fokas@uk-koeln.de",{"name":22,"role":26,"phone":30,"phoneExt":19,"email":19},"+49 22147884763",[32,48,63,77],{"facility":33,"status":19,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Klinikverbund Allgäu","Kempten","BaBaden-Württembergs","87439","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],7.93702,49.96729,{"lat":43,"lon":42},[46],{"name":47,"role":26,"phone":19,"phoneExt":19,"email":19},"Florian f Sterzing, Prof. Dr. med.",{"facility":49,"status":19,"city":50,"state":51,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Frankfurt Universitätsklinikum","Frankfurt am Main","Hesse","60590",{"type":40,"coordinates":54},[55,56],8.68417,50.11552,{"lat":56,"lon":55},[59],{"name":60,"role":26,"phone":61,"phoneExt":19,"email":62},"Markus M Diefenhardt, PD Dr.","+49 60 6301-5130","strahlentherapie@unimedizin-ffm.de",{"facility":64,"status":19,"city":65,"state":66,"zip":67,"country":37,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Klinik für Strahlentherapie, Cyberknife und Radioonkologie Universität zu Köln","Cologne","North Rhine-Westphalia","50937",{"type":40,"coordinates":69},[70,71],6.95,50.93333,{"lat":71,"lon":70},[74],{"name":75,"role":26,"phone":76,"phoneExt":19,"email":28},"Emmanouil E Fokas, Prof. Dr. med. Dr.","+49 221 478-84763",{"facility":78,"status":19,"city":79,"state":80,"zip":81,"country":37,"countryCode":38,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Leipzig, Universitätsklinikum","Leipzig","Saxony","04103",{"type":40,"coordinates":83},[84,85],12.37129,51.33962,{"lat":85,"lon":84},[88],{"name":89,"role":26,"phone":90,"phoneExt":19,"email":19},"Thomas t Kuhnt, Prof. Dr.","+49 341 97-16650",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Prof. Dr. med. Dr. Emmanouil Fokas","Prof Dr. med. Dr.","100572159","external-beam-radiotherapy-combined-with-endorectal-high-dose-rate-brachytherapy-in-elderly-and-frail-patients-with-rectal-cancer-100572159",false,"NCT06729645","External Beam Radiotherapy Combined With Endorectal High-dose-rate Brachytherapy in Elderly and Frail Patients With Rectal Cancer","ACO\u002FARO\u002FAIO-22 - External Beam Radiotherapy Combined With Endorectal High-dose-ratebrachytherapy in Elderly and Frail Patients With Rectal Cancer. A Prospective Multicentre Trial of the German Rectal Cancer Study Group","ACO\u002FARO\u002FAIO-22","Inclusion Criteria:\n\n* Elderly patients (age ≥70 years) with a G8-frailty score ≤ 14 based on the G8 geriatric assessment tool of frailty and\u002For elderly patients (age ≥70 years) with American Society of Anesthesiologists Physical Status (ASA PS) ≥ 3 and\u002F elderly patients (age ≥70 years) unsuitable to tolerate radical surgery as judged by the surgeon and\u002For elderly patients (age ≥70 years) that refuse radical surgery\n* Life expectancy ≥ 6 months\n* Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0-16 cm from the anocutaneous line as measured by rigid rectoscopy\n* MRI-defined cT1-3d N0\u002F+ M0, mrCRM - \u002F +, \\\u003C\u002F= 2\u002F3 involvement of the rectal wall circumference\n* Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.\n* Spiral-CT of the abdomen and chest to exclude distant metastases.\n\nExclusion Criteria:\n\n* Previous or current drug abuse\n* Other concomitant antineoplastic therapy\n* Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-\n\n  1), unless the patient is continuously disease-free\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","70 Years",{"count":106,"type":107},80,"ESTIMATED","INTERVENTIONAL",[110],"NA","ACO\u002FARO\u002FAIO-22 - External beam radiotherapy combined with endorectal high-dose-ratebrachytherapy in elderly and frail patients with rectal cancer.\n\nA prospective multicentre trial of the German Rectal Cancer Study Group.",[113],"Rectal Cancer","NOT_YET_RECRUITING","2026-04-27",{"date":117,"type":118},"2026-05-01","ACTUAL",{"date":120,"type":107},"2026-09-30",{"date":122,"type":107},"2031-12-30",{"name":5,"class":6},4]