{"groups":[{"description":"IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)","id":"FG000","title":"Regimen I (Dactinomycin)"},{"description":"institutional preference of either:\n\n* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR\n* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.","id":"FG001","title":"Regimen II (Methotrexate)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Ineligible"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"}],"type":"STARTED"},{"achievements":[{"comment":"treated for 3 cycles after hCG \\<5mIU/ml or until biologic,disease progression, unacceptable toxicity","groupId":"FG000","numSubjects":"28"},{"comment":"treated for 3 cycles after hCG \\<5mIU/ml or until biologic,disease progression, unacceptable toxicity","groupId":"FG001","numSubjects":"26"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.","recruitmentDetails":"The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual."}