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Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Unique Dataset IDNCT00392327
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients85RandomizationYesPubMed (PMID)30332335.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiological, Drug, RadiationDataset TypeOther

Clinical Trial Title

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Trial Summary and Conditions

This 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.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients. II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients. SECONDARY OBJECTIVES: I. To compare residual disease response to radiation alone versus radiation plus carboplatin. II. To identify molecular prognostic indicators suitable for patient stratification in future trials. III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities. IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life. OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15).

Outcome Measures

Primary: Event-free survival (EFS) percentage [ Time Frame: Time from disease progression or recurrence, occurrence of a second malignant neoplasm, or death from any cause, assessed up to 10 years ] Secondary: Tumor response to radiation therapy with or without carboplatin [ Time Frame: Up to 10 years ] Time to death [ Time Frame: Up to 10 years ]

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00392327-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.

Available Downloads: NCT00392327-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00392327-D2-Data-Dictionary_1.pdf

DATA: NCT00392327-D2-Dataset.csv


Available Downloads: NCT00392327-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00392327-D1-Data-Dictionary_1.pdf

DATA: NCT00392327-D1-Dataset_1.csv