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Type(s) of Cancer
Brain
Study Phase
Phase 3
Study Completion Date
June 2019
NCT00392327Uploaded 07-10-2019
Access via NCI by Request
PDS UID - nci-data-399
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
Provider Information
Provider Data DescriptionNCT00392327-D2-Dataset The second dataset (D2) contains data provided by the central pathologist on the 10 patients who were selected for a second central pathology review, given the discrepancies between profiling and centrally reviewed histopathologic diagnoses. This second central pathology review was done at the request of one of the journal article reviewers. The text in the results section of the manuscript and the associated data are geared towards pathologists rather than the general readership.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset85
# of Patients Control23
# of Patients Experimental23
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
ConditionsAnaplastic Medulloblastoma
Medulloblastoma
Intervention TypeDrug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug(s)Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Drug: Carboplatin
Drug: Isotretinoin
Total Enrolled379
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (chemoradiotherapy) - Active Comparator
Arm B (chemoradiotherapy) - Experimental
Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Secondary IDNCI-2009-00336
PubMed (PMID)30332335
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
Puerto Rico
Age RangeMinimum Age: 3 Years
Maximum Age: 21 Years
Files: NCT00392327-D2
Data DictionaryNCT00392327-D2-Data-Dictionary_1.pdf
DATANCT00392327-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00392327-D1
Data DictionaryNCT00392327-D1-Data-Dictionary_1.pdf
DATANCT00392327-D1-Dataset_1.csv
OTHERREADME.pdf
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