{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.50","upperLimit":"39.63","value":"30.88"},{"groupId":"OG001","lowerLimit":"22.40","upperLimit":"38.88","value":"30.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"150"}],"units":"Participants"}],"description":"Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.","dispersionType":"95% Confidence Interval","groups":[{"description":"INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"OG000","title":"Regimen A (VDC/IE)"},{"description":"INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nMAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nGanitumab: Given IV\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"OG001","title":"Regimen B (VDC/IE + Ganitumab)"}],"paramType":"NUMBER","populationDescription":"Only eligible patients are considered in the calculation of this outcome measure.","reportingStatus":"POSTED","timeFrame":"5 years after enrollment","title":"Event-free Survival","type":"PRIMARY","unitOfMeasure":"percent probability of participants"}