[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579361":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":50,"locations":57,"responsibleParty":111,"collaborators":113,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":10,"enrollmentInfo":129,"targetDuration":132,"studyType":133,"phases":10,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":142,"whyStopped":10,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Turkish Society of Colon and Rectal Surgery","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront TME group",null,"Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy",[13],"Other: Total mesorectal excision",{"label":15,"type":10,"description":16,"interventionNames":17},"Neoadjuvant chemoradiotherapy group","Patients who received neoadjuvant chemoradiotherapy before surgery",[18],"Other: Neoadjuvant Chemotherapy followed by total mesorectal excision",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Total mesorectal excision","Direct surgery without receiving neoadjuvant chemoradiotherapy",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Neoadjuvant Chemotherapy followed by total mesorectal excision","Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy\u002Fradiotherapy\u002Fchemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery",[15],[29,33,37,40,43,47],{"name":30,"affiliation":31,"role":32},"Feza Karakayali, Prof.","Baskent University","STUDY_CHAIR",{"name":34,"affiliation":35,"role":36},"Aras Emre Canda, Prof.","Acibadem Kent Hospital","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Ilknur Erenler Bayraktar, Prof.","Halic University",{"name":41,"affiliation":42,"role":36},"Onur Bayraktar, Prof.","Memorial Sisli Hospital",{"name":44,"affiliation":45,"role":46},"Cigdem N Arslan, Prof.","Istanbul Health and Technology University","STUDY_DIRECTOR",{"name":48,"affiliation":49,"role":36},"Tayfun Bisgin, Prof.","Dokuz Eylul University",[51,55],{"name":44,"role":52,"phone":53,"phoneExt":10,"email":54},"CONTACT","+905421454435","cigdemarslan@hotmail.it",{"name":30,"role":52,"phone":53,"phoneExt":10,"email":56},"fezaykar@yahoo.com",[58,70,81,90,102],{"facility":31,"status":10,"city":59,"state":10,"zip":10,"country":60,"countryCode":10,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Ankara","Turkey (Türkiye)",{"type":62,"coordinates":63},"Point",[64,65],32.85427,39.91987,{"lat":65,"lon":64},[68,69],{"name":30,"role":52,"phone":10,"phoneExt":10,"email":56},{"name":30,"role":36,"phone":10,"phoneExt":10,"email":10},{"facility":45,"status":10,"city":71,"state":10,"zip":72,"country":60,"countryCode":10,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Istanbul","34394",{"type":62,"coordinates":74},[75,76],28.94966,41.01384,{"lat":76,"lon":75},[79,80],{"name":44,"role":52,"phone":10,"phoneExt":10,"email":54},{"name":44,"role":36,"phone":10,"phoneExt":10,"email":10},{"facility":82,"status":10,"city":71,"state":10,"zip":10,"country":60,"countryCode":10,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Memorial sisli Hospital",{"type":62,"coordinates":84},[75,76],{"lat":76,"lon":75},[87,89],{"name":41,"role":52,"phone":10,"phoneExt":10,"email":88},"dronurbayraktar@gmail.com",{"name":41,"role":36,"phone":10,"phoneExt":10,"email":10},{"facility":35,"status":10,"city":91,"state":10,"zip":10,"country":60,"countryCode":10,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Izmir",{"type":62,"coordinates":93},[94,95],27.13838,38.41273,{"lat":95,"lon":94},[98,101],{"name":99,"role":52,"phone":10,"phoneExt":10,"email":100},"Aras Emre Canda, Prof","candaae@gmail.com",{"name":34,"role":36,"phone":10,"phoneExt":10,"email":10},{"facility":49,"status":10,"city":91,"state":10,"zip":10,"country":60,"countryCode":10,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},{"type":62,"coordinates":104},[94,95],{"lat":95,"lon":94},[107,110],{"name":108,"role":52,"phone":10,"phoneExt":10,"email":109},"Tayfun Bisgin, Assoc. Prof.","tayfun.bisgin@gmail.com",{"name":108,"role":36,"phone":10,"phoneExt":10,"email":10},{"type":112,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[114,115,116,117,118],{"name":31,"class":6},{"name":49,"class":6},{"name":39,"class":6},{"name":35,"class":6},{"name":45,"class":6},"100579361","can-neoadjuvant-chemoradiotherapy-be-ommited-in-mid-rectal-cancer-100579361",false,"NCT06823297","Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer","Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study","CANO","Inclusion Criteria:\n\n* Pathologically confirmed rectal cancer\n* Rectal cancer within 6-12 cm from anal verge confirmed by sigmoidoscopy or located between the anorectal junction and peritoneal reflection identified by MRI\n* Clinical local staging performed by MRI\n* cT2N+, cT3N0 and cT3N+ tumors\n* Patients without mesorectal fascia involvement assessed by MRI (≤1 mm)\n* Patients without pathological (short axis ≥7 mm) lateral (extramesorectal) lymph nodes on MRI\n* Patients without EMVI on MRI\n\nExclusion Criteria:\n\n* cT4 tumors\n* Stage IV disease\n* Patients with MSI (+) in TME pathology\n* PAtients who received neoadjuvant immunotherapy\n* Emergency surgery\n* Clinical obstruction\n* Previous pelvic radiotherapy\n* Patients treated without a multidisciplinary council decision\n* Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)\n* Familial adenomatous polyposis (FAP), attenuated FAP, and other polyposis syndromes\n* Hereditary non-polyposis colorectal cancer (Lynch syndrome)\n* Synchronous colon tumors","ALL","18 Years",{"count":130,"type":131},436,"ESTIMATED","5 Years","OBSERVATIONAL","This project aims to compare the oncological and functional outcomes of patients with mid-rectal cancer who have a low risk of local recurrence (without MRF involvement) and who either receive or do not receive neoadjuvant chemoradiotherapy (nCRT).\n\nMain Question:\n\nH0: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), there is no difference in 3-year disease-free survival between direct TME and TME after nCRT.\n\nH1: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), direct TME is associated with worse 3-year disease-free survival compared to TME after nCRT.\n\nParticipants already taking both interventions as part of their regular medical care for rectal cancer will be recruited in a prospective database for 5 years.",[136,137,138],"Mid-Rectal Cancer","Rectal Cancer Stage II","Rectal Cancer Stage III",[136,140,141],"Radiotherapy","Mesorectal fascia","NOT_YET_RECRUITING","2025-06-23",{"date":145,"type":146},"2025-06-27","ACTUAL",{"date":148,"type":131},"2025-08-01",{"date":150,"type":131},"2035-08-01",{"name":5,"class":6},5]