{"groups":[{"description":"Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses","id":"FG000","title":"MTX + AraC"},{"description":"Arm B Rituximab 375 mg/m2 conventional infusion d -5 \\& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses\n\nRituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \\& 0 every 3 weeks for a maximum of 4 cycles","id":"FG001","title":"MTX + Ara-C + Rituximab"},{"description":"Arm C Rituximab 375 mg/m2 conventional infusion d -5 \\& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses\n\nRituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \\& 0 every 3 weeks for a maximum of 4 cycles\n\nThiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4","id":"FG002","title":"MTX + Ara-C + Rituximab+Thiotepa"},{"description":"ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.\n\nradiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.","id":"FG003","title":"WBRT 36 Gy +/- Boost 9 Gy"},{"description":"Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0\n\nThiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4\n\nBCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6\n\nAPBSCT: Autologous peripheral blood stem cell transplant (APBSCT)","id":"FG004","title":"BCNU + Thiotepa + APBSCT"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Progressive Disease"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"75"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"66"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"First Randomization"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"}],"type":"Progressive Disease"}],"milestones":[{"achievements":[{"comment":"After first randomization, patients were randomized to Arm D and Arm E","groupId":"FG000","numSubjects":"0"},{"comment":"After first randomization, patients were randomized to Arm D and Arm E","groupId":"FG001","numSubjects":"0"},{"comment":"After first randomization, patients were randomized to Arm D and Arm E","groupId":"FG002","numSubjects":"0"},{"comment":"113 patients proceeded to second randomization. See Pre-assignment details","groupId":"FG003","numSubjects":"55"},{"comment":"113 patients proceeded to second randomization. See Pre-assignment details","groupId":"FG004","numSubjects":"58"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"52"},{"groupId":"FG004","numSubjects":"54"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Second Randomization"}],"preAssignmentDetails":"At the end of first randomization 167 patients with responsive or stable disease were observed . Eighteen patients experienced PD before the second randomization, 12 were deemed unfit, and 15 had no harvest.\n\nConsequently, 122 patients were eligible and assessable for second randomization. Four patients refused the second randomization, leaving 59 patients allocated to Arm D and 59 to Arm E.\n\nOf these, five patients refused consolidation resulting in 113 patients proceeding","recruitmentDetails":"Two hundreds and twenty seven patients were enrolled and treated in the IELSG32 study.\n\nEight patients were excluded (five from arm B and three from arm C) because of misdiagnosis, systemic lymphoma, or concomitant cancer."}