{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.","nonInferiorityType":"OTHER","pValue":".1022","paramType":"Log Rank Test Statistic","paramValue":"2.6709","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"100.0","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"89.0","upperLimit":"100.0","value":"95.4"},{"groupId":"OG002","lowerLimit":"89.4","upperLimit":"100.0","value":"96.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"28"}],"units":"Participants"}],"title":"OS w/complete surgical resection"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"97.2","upperLimit":"100.0","value":"99.1"},{"groupId":"OG001","lowerLimit":"88.4","upperLimit":"98.6","value":"93.5"},{"groupId":"OG002","lowerLimit":"77.0","upperLimit":"96.0","value":"86.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"53"}],"units":"Participants"}],"title":"OS w/o complete surgical resection"}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"81"}],"units":"Participants"}],"description":"To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.","dispersionType":"95% Confidence Interval","groups":[{"description":"2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.","id":"OG000","title":"Group 2 (Chemotherapy, Surgery)"},{"description":"4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.","id":"OG001","title":"Group 3 (Chemotherapy, Surgery)"},{"description":"8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \\< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.","id":"OG002","title":"Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)"}],"paramType":"NUMBER","populationDescription":"Eligible and evaluable intermediate risk patients with reported surgery.","reportingStatus":"POSTED","timeFrame":"Up to 10 years","title":"Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates","type":"PRIMARY","unitOfMeasure":"percentage of OS rate"}