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Boston, Massachusetts 02114


Purpose:

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. PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.


Study summary:

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 radiotherapy. - Determine the incidence of primary hypothyroidism and other endocrine dysfunction (neuroendocrine and end organ) in patients treated with this regimen. - Determine the incidence and severity of neurocognitive abnormalities in patients treated with this regimen. - Determine the acute side effects of this regimen, including esophagitis, upper and lower gastrointestinal tract disease, and weight loss, in these patients. - Determine the 3-year progression-free survival rate of patients treated with this regimen. OUTLINE: Patients are stratified according to risk (standard vs high). Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days a week for 6-8 weeks*. NOTE: *Unless otherwise specified by a co-existing protocol. Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at baseline and then annually for 5 years; and audiology evaluation at baseline, before each course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years. After completion of study treatment, patients are followed every 3-6 months for 2-5 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.


Criteria:

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


NCT ID:

NCT00105560


Primary Contact:

Study Chair
Nancy J. Tarbell, MD
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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