[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477401":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":50,"locations":59,"responsibleParty":90,"collaborators":64,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":64,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":64,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":62,"whyStopped":64,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Larissa University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy","EXPERIMENTAL","The experimental group will receive the standard 5-week neoadjuvant chemoradiotherapy (CRT). Thereafter, all patients will commence consolidation chemotherapy. At the 6th week after the end of CRT, patients will undergo MRI re-staging: In case of non-response (mrTRG 5) they will be submitted immediately to surgery, and, subsequently, excluded from the trial.\n\nIn case of response (mrTRG 2-4) they will receive consolidation chemotherapy for the whole waiting period between the end of CRT and surgery - 12 weeks.",[13,14],"Radiation: Neoadjuvant Chemoradiotherapy","Drug: Consolidation Chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy","ACTIVE_COMPARATOR","The control group will receive the standard 5-week neoadjuvant chemoradiotherapy regimen. Six weeks after completion the patient will be re-staged with rectal MRI and depending on the response will be operated (TME): immediately in case of non-response (mrTRG 5) or after an additional 6-week delay (overall 12 weeks after the end of chemoradiotherapy) in case of partial response (mrTRG 2-4). Adjuvant chemotherapy will be, also, administered.",[13,20],"Drug: Adjuvant Chemotherapy",[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Neoadjuvant Chemoradiotherapy","5-week neoadjuvant radiotherapy regimen (28 x 1.8 Gy) combined with Capecitabine (bid 800 mg\u002Fm2, twice daily, on days 1-33-38)",[16,9],[28],"nCRT",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Adjuvant Chemotherapy","8 cycles of CAPOX (Capecitabine bid 1000 mg\u002Fm2, twice daily, day 1-14, every 3 weeks and Oxaliplatin 130 mg\u002Fm2, day 1, every 3 weeks) or alternatively, 12 cycles of folinate, fluorouracil and oxaliplatin (FOLFOX)",[16],[35],"AC",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Consolidation Chemotherapy","CAPOX (Capecitabine bid1000 mg\u002Fm2 and Oxaliplatin 130 mg\u002Fm2, day 1, every 3 weeks) or alternatively FOLFOX",[9],[41],"CC",[43,47],{"name":44,"affiliation":45,"role":46},"Konstantinos Perivoliotis, MD","University Hospital of Larissa","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":45,"role":49},"George Tzovaras, Prof","STUDY_DIRECTOR",[51,56],{"name":44,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","2413501000","0030","kperi19@gmail.com",{"name":48,"role":52,"phone":57,"phoneExt":54,"email":58},"2413502804","gtzovaras@hotmail.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Department of Surgery, University Hospital of Larissa","RECRUITING","Larissa",null,"41110","Greece","GR",{"type":69,"coordinates":70},"Point",[71,72],22.42112,39.62847,{"lat":72,"lon":71},[75,77,80,81,84,86,88],{"name":44,"role":52,"phone":76,"phoneExt":64,"email":55},"00302413501000",{"name":78,"role":52,"phone":79,"phoneExt":64,"email":58},"George Tzovaras, Professor","00302413502804",{"name":44,"role":46,"phone":64,"phoneExt":64,"email":64},{"name":82,"role":83,"phone":64,"phoneExt":64,"email":64},"Ioannis Baloyiannis, Prof","SUB_INVESTIGATOR",{"name":85,"role":83,"phone":64,"phoneExt":64,"email":64},"Ioannis Samaras, MD",{"name":87,"role":83,"phone":64,"phoneExt":64,"email":64},"Athanasios Kotsakis, Prof",{"name":89,"role":83,"phone":64,"phoneExt":64,"email":64},"Georgios Kyrgias, Prof",{"type":46,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Perivoliotis Konstantinos","Perivoliotis Konstantinos, Principal Investigator","100477401","neoadjuvant-chemoradiotherapy-and-consolidation-chemotherapy-for-rectal-cancer-a-randomized-controlled-trial-100477401",false,"NCT05496491","Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma\n* cT3, cT4, threatened CRM \u002F MRF, EMVI (+), ≥N1\n* Multidisciplinary tumor board decision for neoadjuvant treatment\n* Tumor distance from the anal verge \\\u003C15 cm based on endoscopy or magnetic resonance imaging\n* Patient 18 to 80 years old\n* General health condition status WHO 0-1\n* Absence of co-morbidities that may affect treatment\n* Neutrophils \\>1,500 \u002F mm3, platelets \\>100,000 \u002F mm3, hemoglobin\\> 10 g \u002F dL, normal creatinine, and creatinine clearance\\> 50 mL \u002F min\n* Signed informed consent of the patient\n\nExclusion Criteria:\n\n* Distant metastases\n* Non-resectable cancer\n* Contraindications for the administration of chemotherapy\n* Previous pelvic radiotherapy or chemotherapy\n* History of inflammatory bowel disorders\n* History of angina, acute myocardial infarction or heart failure\n* Active sepsis or systemic infection\n* Untreated physical and mental disability\n* Synchronous malignancy\n* Pregnancy or breast-feeding\n* Lack of compliance with the protocol process\n* Non-granting of signed informed consent","ALL","18 Years","80 Years",{"count":103,"type":104},84,"ESTIMATED","INTERVENTIONAL",[107],"NA","The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.",[110],"Rectal Neoplasms",[112,113,114,115,116,117,118],"rectal","cancer","neoadjuvant","radiotherapy","chemotherapy","mesorectal","excision","2024-10-07",{"date":121,"type":122},"2024-10-08","ACTUAL",{"date":124,"type":122},"2022-08-30",{"date":126,"type":104},"2026-08-30",{"name":5,"class":6},1]