{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"RECIST PR, no AFP response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"}]}],"title":"AFP response, no RECIST response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}]}],"title":"RECIST response, AFP response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"18"}]}],"title":"no AFP response, no RECIST response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"RECIST v 1.1 and serum alphafetoprotein responses are evaluated separately. RECIST v 1.1 complete response (CR) is defined as disappearance of all target lesions and partial response (PR) is defined as reduction of at last 30% in the sum of the longest dimension of all target lesions (CR and PR measured by CT or MRI) between enrollment. Serum alphafetoprotein response is a decrease of at least 90% from the last serum alphafetoprotein measurement from the baseline prior to the start of chemotherapy to the end of cycle 2. This is calculated for HIGH RISK regimen W and HIGH RISK regimen H only.","groups":[{"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":"OG000","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":"OG001","title":"High-risk Group (Regimen H)"}],"paramType":"NUMBER","populationDescription":"Thirty-two (32) patients were enrolled to Regiment W. Two were excluded from the analysis: (1)one was ineligible; and (2) one did not have an accurate report of initial AFP. Forty (40) patients were enrolled to Regiment H. Five were excluded from the analysis: (1)four were ineligible; and (2) one did not receive Temsirolimus.","reportingStatus":"POSTED","timeFrame":"First two cycles of therapy- up to 42 days after enrollment","title":"Disease Status at the End of 2 Courses of Therapy","type":"PRIMARY","unitOfMeasure":"participants"}