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limb"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"Agitation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Hallucinations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Acute kidney injury"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"Renal and urinary disorders - Other, specify"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Renal calculi"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Proteinuria"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Erythema multiforme"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Skin and subcutaneous tissue disorders - Other, specify"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}],"title":"Rash maculo-papular"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Eye disorders - Other, specify"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Surgical and medical procedures - Other, specify"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"Tumor pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}],"title":"Allergic reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}],"title":"Anaphylaxis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Immune system disorders - Other, specify"}],"denomUnitsSelected":"Cycles","denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"105"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"40"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"107"},{"groupId":"OG003","value":"124"}],"units":"Cycles"}],"description":"All grade 3 or 4 or greater non-hematological toxicities. The frequency of each toxicity type will be quantified as the number of reporting periods on which the toxicity of the relevant grade is reported. This measure does not apply to patients enrolled in the VERY LOW RISK group.","groups":[{"description":"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\nCisplatin: Given IV\n\nFluorouracil: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"OG000","title":"Low-risk Group (Regimen T)"},{"description":"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)\n\nCisplatin: Given IV\n\nDexrazoxane: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiver Transplantation: Undergo liver transplant\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"OG001","title":"Intermediate-risk Group (Regimen F)"},{"description":"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.\n\nCisplatin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"OG002","title":"High-risk Group (Regimen W)"},{"description":"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.\n\nCisplatin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiver Transplantation: Undergo liver transplant\n\nTemsirolimus: Given IV\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"OG003","title":"High-risk Group (Regimen H)"}],"paramType":"NUMBER","populationDescription":"All eligible patients except for patients in the very low-risk group. Regimen T includes 49 cycles, Regimen F includes 269 cycles, Regimen W includes 107 cycles and Regimen H includes 124 cycles.","reportingStatus":"POSTED","timeFrame":"During protocol therapy up to 1 year after enrollment","title":"Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed","type":"PRIMARY","typeUnitsAnalyzed":"Cycles","unitOfMeasure":"Cycles"}