Status:
COMPLETED
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Long-term Effects Secondary to Cancer Therapy in Children
Eligibility:
All Genders
3-21 years
Phase:
NA
Brief Summary
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. P...
Detailed Description
OBJECTIVES: * Determine the 3-year incidence and severity of ototoxicity in young patients with medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and posterior fossa rad...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed medulloblastoma or pineoblastoma
- Standard-risk or high-risk disease
- Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days
- Requires craniospinal irradiation
- PATIENT CHARACTERISTICS:
- Age
- 3 to 21
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No more than 1 prior chemotherapy regimen
- No prior IV or intrathecal methotrexate
- No prior intrathecal thiotepa
- Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00105560
Start Date
May 1 2002
End Date
December 1 2020
Last Update
December 28 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114