[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551589":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":59,"overallOfficials":89,"centralContacts":93,"locations":102,"responsibleParty":119,"collaborators":37,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":37,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":37,"overallStatus":105,"whyStopped":37,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"complete response (CR) rate","Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\\&W strategy.","1 month after the surgery or the decision of W&W",[14,18,21,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Grade 3-4 adverse effects rate","Rate of chemotherapy, radiotherapy and immunotherapy related adverse events","From date of randomization until 3 months after the completion neoadjuvant therapy",{"measure":19,"description":19,"timeFrame":20},"Organ preservation rate","from date of receiving neoadjuvant therapy, assessed up to 3 years",{"measure":22,"description":23,"timeFrame":24},"3 year disease free survival rate","Rate of 3 year disease free survival","From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.",{"measure":26,"description":27,"timeFrame":28},"3 year local recurrence free survival rate","Rate of 3 year local recurrence free survival","From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.",{"measure":30,"description":31,"timeFrame":32},"3 year overall survival rate","Rate of 3 year overall survival","From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.",{"measure":34,"description":35,"timeFrame":36},"3 year Quality of Life","Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.","From date of initiation of treatment until the date of death from any cause, assessed up to 3 years",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45,54],{"label":46,"type":47,"description":48,"interventionNames":49},"Short-course Radiotherapy plus immunochemotherapy group","EXPERIMENTAL","The patients will receive short-course radiotherapy (25Gy\u002F5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.",[50,51,52,53],"Radiation: Short-course radiotherapy","Drug: PD-1 antibody (Toripalimab)","Drug: Oxaliplatin","Drug: Capecitabine",{"label":55,"type":47,"description":56,"interventionNames":57},"Long-course Radiotherapy plus chemotherapy group","The patients will receive long-course radiotherapy (50Gy\u002F25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.",[58,52,53],"Radiation: Long-course radiotherapy",[60,67,74,80,84],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"RADIATION","Short-course radiotherapy","Short-course radiotherapy: 25Gy\u002F5Fx",[46],[66],"SCRT",{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","PD-1 antibody (Toripalimab)","Toripalimab 240mg d1 q3w",[46],[73],"Toripalimab",{"type":61,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Long-course radiotherapy","Long-course radiation: 50Gy\u002F25Fx",[55],[79],"LCRT",{"type":68,"name":81,"description":82,"armGroupLabels":83,"otherNames":37},"Oxaliplatin","Oxaliplatin: 130mg\u002Fm2 d1 q3w",[55,46],{"type":68,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Capecitabine","Xeloda",[55,46],[86],[90],{"name":91,"affiliation":5,"role":92},"Zhen Zhang, M.D, PH.D","PRINCIPAL_INVESTIGATOR",[94,98],{"name":91,"role":95,"phone":96,"phoneExt":96,"email":97},"CONTACT","18801735029","zhen_zhang@fudan.edu.cn",{"name":99,"role":95,"phone":100,"phoneExt":37,"email":101},"Yajie Chen, PH.D","18917239680","16111230008@fudan.edu.cn",[103],{"facility":104,"status":105,"city":106,"state":37,"zip":37,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":110,"coordinates":111},"Point",[112,113],121.45806,31.22222,{"lat":113,"lon":112},[116],{"name":117,"role":95,"phone":118,"phoneExt":37,"email":97},"Zhen Zhang, MD, PHD","021-64175590",{"type":92,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Zhen Zhang","Professor","100551589","phase-2-short-course-radiotherapy-combined-with-capox-and-pd-1-antibody-versus-long-course-chemoradiotherapy-combined-with-capox-for-early-low-lying-rectal-cancer-100551589",false,"NCT06462053","Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","TORCH-E2","Inclusion Criteria:\n\n1. age 18-75 years old, female and male\n2. pathological confirmed adenocarcinoma\n3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm\n4. the distance from anal verge less than 5 cm\n5. without distance metastases\n6. KPS \\>=70\n7. with good compliance\n8. microsatellite repair status is MSS\u002FpMMR\n9. without previous anti-cancer therapy or immunotherapy\n10. signed the inform consent\n\nExclusion Criteria:\n\n1. pregnancy or breast-feeding women\n2. pathological confirmed signet ring cell carcinoma\n3. clinical stage T1N0 and can be resected locally\n4. history of other malignancies within 5 years\n5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.\n6. immunodeficiency disease or long-term using of immunosuppressive agents\n7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\\^9\u002FL, Hb≥90g\u002FL, PLT≥100×10\\^9\u002FL, ALT\u002FAST ≤2.5 ULN, Cr≤ 1 ULN\n8. DPD deficiency\n9. allergic to any component of the therapy","ALL","18 Years","75 Years",{"count":134,"type":135},134,"ESTIMATED","INTERVENTIONAL",[138],"PHASE2","TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b\u002FN0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy\u002F5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy\u002F25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.",[141],"Early Low Rectal Cancer","2024-06-12",{"date":144,"type":145},"2024-06-17","ACTUAL",{"date":147,"type":145},"2024-04-01",{"date":149,"type":135},"2027-03-01",{"name":5,"class":6},1]