{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"OTHER","pValue":".0253","paramType":"Log-Rank Test Statistic","paramValue":"5.0049","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"90.0","upperLimit":"100.0","value":"95.4"},{"groupId":"OG001","lowerLimit":"78.7","upperLimit":"98.1","value":"88.4"},{"groupId":"OG002","lowerLimit":"63.4","upperLimit":"93.8","value":"78.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"28"}],"units":"Participants"}],"title":"EFS w/complete surgical resection"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"74.6","upperLimit":"89.8","value":"82.2"},{"groupId":"OG001","lowerLimit":"77.7","upperLimit":"92.4","value":"85.1"},{"groupId":"OG002","lowerLimit":"56.3","upperLimit":"82.1","value":"69.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"53"}],"units":"Participants"}],"title":"EFS 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 EFS, 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, Event Free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"percentage of 3 yr EFS survival"}