{"analyses":[{"groupDescription":"Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.","groupIds":["OG000"],"nonInferiorityComment":"The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0005","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.6","upperLimit":"18.5","value":"10.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"}],"units":"Participants"}],"description":"The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost","id":"OG000","title":"Cohort B - No Chemotherapy"}],"paramType":"NUMBER","populationDescription":"All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)","reportingStatus":"POSTED","timeFrame":"2 years after start of treatment (+/- 3 months)","title":"Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria","type":"PRIMARY","unitOfMeasure":"percentage of participants"}