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Type(s) of Cancer
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
2016-03-31
NCT00085735Uploaded 09-23-2023
Access via NCI by Request
PDS UID: nci-data-524
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
Provider Information
Provider Data DescriptionThere is one data submission associated with PMID 34110925: NCT00085735-D1. This dataset provides the information for baseline characteristics, primary analyses, adverse events, molecular analyses, and QOL analyses reported in the manuscript, figures, and tables. There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.
ConditionsUntreated Childhood Medulloblastoma
Intervention TypeDrug: Cisplatin
Radiation: Craniospinal Irradiation
Drug: Cyclophosphamide
Radiation: Involved-Field Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: Lomustine
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug(s)Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Lomustine
Drug: Vincristine Sulfate
Total Enrolled549
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (3-7 years of age, LDCSI, IFRT) - Experimental
Arm II (3-7 years of age, LDCSI, PFRT) - Experimental
Arm III (3-7 years of age, SDCSI, IFRT) - Experimental
Arm IV (3-7 years of age, SDCSI, PFRT) - Active Comparator
Arm V (8-21 years of age, SDCSI, IFRT) - Experimental
Arm VI (8-21 years of age, SDCSI, PFRT) - Active Comparator
Secondary IDNCI-2009-00335
PubMed (PMID)34110925
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
New Zealand
Switzerland
Age Range3 Years to 21 Years (CHILD, ADULT)
Files: NCT00085735-D1
Data DictionaryNCT00085735-D1-Data-Dictionary_1.pdf
DATANCT00085735-D1-Dataset.CSV
OTHERREADME.pdf
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