{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}],"title":"Complete Response"},{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"24"}],"title":"Partial Response"},{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"54"},{"groupId":"OG003","value":"53"}],"title":"Stable Disease"},{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"32"}],"title":"Progressive Disease/other"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"108"},{"groupId":"OG002","value":"112"},{"groupId":"OG003","value":"111"}],"units":"Participants"}],"description":"RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.","groups":[{"description":"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.\n\nCisplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG000","title":"Arm I (Paclitaxel, Cisplatin)"},{"description":"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.\n\nCisplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nVinorelbine Tartrate: Given IV","id":"OG001","title":"Arm II (Vinorelbine, Cisplatin)"},{"description":"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.\n\nCisplatin: Given IV\n\nGemcitabine Hydrochloride\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG002","title":"Arm III (Gemcitabine, Cisplatin)"},{"description":"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.\n\nCisplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopotecan Hydrochloride: Given IV","id":"OG003","title":"Arm IV (Topotecan, Cisplatin)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Evaluable (treatment)","reportingStatus":"POSTED","timeFrame":"Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)","title":"Frequency of Response Using RECIST Version 1.0","type":"SECONDARY","unitOfMeasure":"Participants"}