{"groups":[{"description":"radiation therapy alone\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"FG000","title":"RT Alone"},{"description":"Radiotherapy and concurrent temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"FG001","title":"RT & Concurrent CT"},{"description":"Radiotherapy plus adjuvant temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nadjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"FG002","title":"RT + Adjuvant CT"},{"description":"Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nadjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"FG003","title":"RT & Concurrent CT + Adjuvant CT"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"49"},{"groupId":"FG003","numSubjects":"40"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"28"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"11"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"16"}],"type":"Various different reasons/missing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"189"},{"groupId":"FG001","numSubjects":"188"},{"groupId":"FG002","numSubjects":"186"},{"groupId":"FG003","numSubjects":"188"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"175"},{"groupId":"FG001","numSubjects":"163"},{"groupId":"FG002","numSubjects":"109"},{"groupId":"FG003","numSubjects":"93"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"25"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"95"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The patients were first registered to the trial by authorized sites. For all patients, tumor and blood samples had to be sent for histology review, 1p/19q analysis and O6-Methylguanine-DNA Methyltransferase (MGMT) assay. If inclusion was based on central pathology and 1p/19q diagnosis the patient could be randomized into the trial once found eligible at central assessment.","recruitmentDetails":"After registration step was completed, eligible patients were randomized into the trial within 8 days from the start of radiotherapy; at this time, all baseline requirements for the study had to be fulfilled."}