{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.56","paramType":"3-Year OS","paramValue":"78.2","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.9","upperLimit":"86.4","value":"78.70"},{"groupId":"OG001","lowerLimit":"69.7","upperLimit":"85.9","value":"77.80"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"149"}],"units":"Participants"}],"description":"The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Regimen A (VAC/VI)"},{"description":"Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Regimen B (VAC/VI/Temsirolimus)"}],"paramType":"NUMBER","populationDescription":"As pre-specified in the protocol, patients randomized to Regimen A (VAC/VI) and Regimen B (VAC/VI/Temsirolimus) were included in this analysis. The data was analyzed with revised intention-to-treat approach. Following patients were excluded 4 ineligible patients, 11 feasibility patients and 13 inevaluable patients (due to FOXO1 results or who did not receive maintenance therapy due to an amendment added during the study) .","reportingStatus":"POSTED","timeFrame":"Up to 3 years from study entry","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}