{"preliminary_commentary":{"by_channel":{"x_thread":3,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["vismodegib","cyclophosphamide","cisplatin","vincristine"],["pemetrexed","gemcitabine","cyclophosphamide","cisplatin"],["cyclophosphamide","cisplatin","vincristine"]],"indication":"newly diagnosed medulloblastoma","name":"SJMB12","nct_id":"NCT01878617","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sjmb12-nct01878617. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants in stratum W1 will undergo reduced dose Craniospinal Irradiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum W1: Low Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum W2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum W2: Atypical","type":"EXPERIMENTAL"},{"description":"Participants in stratum W3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum W3: High Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum S1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum S1: Standard Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum S2 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum S2: High Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum N1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum N1: Standard Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum N2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum N2: Intermediate Risk","type":"EXPERIMENTAL"},{"description":"Participants in stratum N3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.","label":"Stratum N3: High Risk","type":"EXPERIMENTAL"}],"collaborators":["Genentech, Inc.","National Cancer Institute (NCI)"],"completion_date":{"date":"2031-10-13","type":"ESTIMATED"},"conditions":["Medulloblastoma"],"enrollment":{"count":660,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Craniospinal Irradiation with boost to the primary tumor site","otherNames":["CSI","Radiation treatments"],"type":"RADIATION"},{"name":"Cyclophosphamide","otherNames":["Cytoxan(R)"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Platinol-AQ(R)"],"type":"DRUG"},{"name":"Vincristine","otherNames":["Oncovin(R)"],"type":"DRUG"},{"name":"Vismodegib","otherNames":["Erivedge(TM)","GDC-0449"],"type":"DRUG"},{"name":"Pemetrexed","otherNames":["Almita(R)"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["Gemzar"],"type":"DRUG"},{"name":"Aerobic Training","otherNames":["Exercise"],"type":"OTHER"},{"name":"Neurocognitive Remediation","otherNames":["Computer-based working memory intervention","Cogmed"],"type":"OTHER"}],"last_update":"2025-11-13","lead_sponsor":"St. Jude Children's Research Hospital","official_title":"A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2028-10-13","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free Survival in Stratum W1","timeFrame":"2 years after diagnosis"},{"measure":"Progression-free Survival in Stratum N1","timeFrame":"2 years after diagnosis"},{"measure":"Progression-free Survival in Stratum S1 Skeletally Mature Cohort","timeFrame":"2 years after diagnosis"},{"measure":"Change in VO2 Peak Value","timeFrame":"baseline and 12 weeks post-randomization"},{"measure":"Change in Spatial Span Backward Standard Score","timeFrame":"baseline and 10-12 weeks post baseline"}],"references":[{"citation":"Gajjar A, Mahajan A, Bale T, Bowers DC, Canan L, Chi S, Cluster A, Cohen K, Cole B, Coven S, Darlington W, Dorris K, Elster J, Ermoian R, Franson A, George E, Helgager J, Landi D, Lin C, Metrock L, Nanda R, Palmer J, Partap S, Plant A, Pruthi S, Reynolds R, Stearns D, Storm P, Wang A, Wang LD, Whipple N, Zaky W, McMillian N, Ramakrishnan S. Pediatric Central Nervous System Cancers, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025 Mar;23(3):113-130. doi: 10.6004/jnccn.2025.0012.","pmid":"40073837","type":"DERIVED"},{"citation":"Khan RB, Patay Z, Klimo P, Huang J, Kumar R, Boop FA, Raches D, Conklin HM, Sharma R, Simmons A, Sadighi ZS, Onar-Thomas A, Gajjar A, Robinson GW. Clinical features, neurologic recovery, and risk factors of postoperative posterior fossa syndrome and delayed recovery: a prospective study. Neuro Oncol. 2021 Sep 1;23(9):1586-1596. doi: 10.1093/neuonc/noab030.","pmid":"33823018","type":"DERIVED"}],"start_date":{"date":"2013-06-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma","url":"https://clinicaltrials.gov/study/NCT01878617"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/sjmb12-nct01878617"}