{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.7","upperLimit":"49.1","value":"25.0"},{"groupId":"OG001","lowerLimit":"12.8","upperLimit":"64.9","value":"35.7"},{"groupId":"OG002","lowerLimit":"0.2","upperLimit":"41.3","value":"9.1"},{"groupId":"OG003","lowerLimit":"9.7","upperLimit":"53.5","value":"27.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"18"}],"units":"Participants"}],"description":"The impact of each treatment regimen on objective response rate (ORR, defined as above in the secondary objective) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \\< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on ORR was explored in Ki-67 low and Ki-67 high separately.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTemozolomide: Given PO","id":"OG000","title":"Arm A (Capecitabine, Temozolomide) -- Ki-67 Low"},{"description":"Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nEtoposide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG001","title":"Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low"},{"description":"Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTemozolomide: Given PO","id":"OG002","title":"Arm A (Capecitabine, Temozolomide) -- Ki-67 High"},{"description":"Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nEtoposide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studie","id":"OG003","title":"Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High"}],"paramType":"NUMBER","populationDescription":"Eligible patients with Ki-67 data","reportingStatus":"POSTED","timeFrame":"assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years, up to 5 years from registration; the best response among all assessments was considered as objective response","title":"To Assess the Objective Response Rate Based on Marker of Proliferation Ki-67 Index","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"percentage of participants"}