{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Incomplete Response (IR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Partial Response (PR)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)\n\nComplete Response (CR): A complete response is defined as one of the following:\n\n* Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).\n* Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.\n* Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.","groups":[{"description":"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.\n\nfilgrastim\n\ncarboplatin\n\nifosfamide\n\npaclitaxel\n\nautologous hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation","id":"OG000","title":"Chemotherapy With Stem Cell Support"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 year","title":"Response","type":"PRIMARY","unitOfMeasure":"participants"}