{"groups":[{"description":"Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.","id":"FG000","title":"No Adjuvant TMZ (Not Randomized)"},{"description":"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.","id":"FG001","title":"Conventional Adjuvant TMZ"},{"description":"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.","id":"FG002","title":"Dose-dense Adjuvant TMZ"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"144"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Ineligible due to insufficient tissue"},{"reasons":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient refusal"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician preference"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other, not otherwise specified"}],"milestones":[{"achievements":[{"comment":"All participants registered to concomitant treatment; randomized after completing this treatment.","groupId":"FG000","numSubjects":"1125"},{"comment":"Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.","groupId":"FG001","numSubjects":"0"},{"comment":"Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.","groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1125"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Eligible Pre-randomization Population"},{"achievements":[{"groupId":"FG000","numSubjects":"1120"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Eligible pre-randomization participants with any follow-up data.","type":"Eligible Pre-randomization Follow-up"},{"achievements":[{"comment":"These participants completed concomitant treatment and met requirements for randomization.","groupId":"FG000","numSubjects":"833"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"292"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Concomitant RT+TMZ (Pre-randomization)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"No follow-up collected"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"411"},{"groupId":"FG002","numSubjects":"422"}],"comment":"Participants who met requirements after concomitant treatment were randomized to an adjuvant arm.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"411"},{"groupId":"FG002","numSubjects":"420"}],"type":"Eligible Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"254"},{"groupId":"FG002","numSubjects":"262"}],"comment":"Eligible participants determined to have unmethylated MGMT.","type":"Unmethylated MGMT Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"122"},{"groupId":"FG002","numSubjects":"122"}],"comment":"Eligible participants determined to have methylated MGMT.","type":"Methylated MGMT Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"96"},{"groupId":"FG002","numSubjects":"95"}],"comment":"Eligible participants who consented to the quality of life study component, offered after 07-12-2007","type":"Quality of Life Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"Randomized participants contributing data to results are considered to have completed the study.","groupId":"FG001","numSubjects":"411"},{"comment":"Randomized participants contributing data to results are considered to have completed the study.","groupId":"FG002","numSubjects":"420"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Randomization to Adjuvant TMZ Arm"}],"preAssignmentDetails":"Sites were required to submit participant tumor tissue for central histologic review and MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for registered participants to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment."}