{"analyses":[{"ciLowerLimit":"0.71","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.44","estimateComment":"The arm having surgery alone was the reference arm.","groupDescription":"Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Time assessment biases were taken into account for the primary endpoint:\n\n* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.\n* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24.","nonInferiorityType":"SUPERIORITY","pValue":"0.955","pValueComment":"A 5% significance level was considered as a threshold for statistical significance.","paramType":"Hazard Ratio (HR)","paramValue":"1.01","statisticalComment":"The time assessment biases correction described before was not applied to patients for whom death was the first event.","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"73"}]}],"title":"No event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"}]}],"title":"Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.","groups":[{"description":"En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.\n\ntherapeutic conventional surgery","id":"OG000","title":"Surgery Alone"},{"description":"3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions\n\ntherapeutic conventional surgery\n\n3-dimensional conformal radiation therapy","id":"OG001","title":"Preoperative Radiotherapy Followed by En-bloc Surgery"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.","title":"Number of Patients With Abdominal Recurrence or Death","type":"PRIMARY","unitOfMeasure":"Participants"}