{"analyses":[{"groupDescription":"To detect a decrease in 3-year cumulative probability of disease-related treatment failure from 30% to 22·5%, corresponding to a hazard ratio (HR) of 0·715, a two sided log-rank test with 280 events would achieve 80% power at a two-sided α significance level of 0·05.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"152"}],"title":"DrTF after 3 year FUP"},{"measurements":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"298"}],"title":"no DrTF after 3 year FUP"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"462"},{"groupId":"OG001","value":"450"}],"units":"Participants"}],"description":"DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait \\& watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.","groups":[{"description":"experimental group (arm B) M1 scheme\n\nM1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX","id":"OG000","title":"B: 5x5Gy -> CAPOX -> Surgery"},{"description":"control group (arm A) standard long course chemoradiotherapy\n\nstandard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.","id":"OG001","title":"A: 5 Weeks Chemoradiation -> Surgery"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"462+450 participants started were eligible 2 + 6 participants were ineligible or withdrew informed consent","reportingStatus":"POSTED","timeFrame":"3 years follow-up after surgery","title":"Number of Patients With Disease Related Treatment Failure (DrTF)","type":"PRIMARY","unitOfMeasure":"Participants"}