A study of Carboplatin with radiotherapy and Isotretinoin in patients with other than average risk medulloblastoma/PNET.
Completed
- Conditions
- brain tumor, medulloblastoma
- Registration Number
- NL-OMON21835
- Lead Sponsor
- International: Children's Oncology Group (COG)Netherlands: Dutch Childhood Oncology Group (DCOG)Childhood Oncology Group (COG)COG Operations Center440 E. Huntington Drive, 4th FloorArcadia, CA 91006-3776USATel: (626) 447-0064
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. Age greater than or equal to 3 and less than 22 years at the time of diagnosis;
2. Newly diagnosed, previously untreated: (1) M0 Medulloblastoma with >1.5 cm2 residual; (2) M+ Medulloblastoma; (3) M0 or M+ Supratentorial PNET (including pineoblastoma). Patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor. All patients with M4 disease are not eligible;
Exclusion Criteria
See general (inclusion) criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Long term event-free survival for high risk<br>medulloblastoma/PNET patients after carboplatin radiosensitization;<br /><br>2. Long term event-free survival for high risk<br>medulloblastoma/PNET patients after Isotretinoin.
- Secondary Outcome Measures
Name Time Method 1. Residual disease response to radiation alone versus radiation plus carboplatin;<br /><br>2. Molecular prognostic indicators suitable for patient stratification in future trials;<br /><br>3. HRQOL during phases of active treatment specific to treatment modalities;<br /><br>4. Neuropsychological functioning of the study population and the relationship between neuropsychological status and health related quality of life.