{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.36","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.595","pValueComment":"A 5% significance level was considered as a threshold for statistical significance.","paramType":"Hazard Ratio (HR)","paramValue":"0.89","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"92"}],"title":"Alive and metastases free (censored)"},{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"41"}],"title":"metastasis and/or death (event)"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"Alive and metastases free patients will be 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":"Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.","title":"Number of Patients With Metastases or Death","type":"SECONDARY","unitOfMeasure":"Participants"}