Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
This trial is active, not recruiting.
|Conditions||brain and central nervous system tumors, long-term effects secondary to cancer therapy in children|
|Sponsor||Massachusetts General Hospital|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 2002|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT00105560, CDR0000415841, MGH-99-271, P01CA021239|
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.
|Intervention model||single group assignment|
This is a single arm study of radiation therapy with protons to standard doses.
Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0
time frame: Annually
Neuroendocrine toxicity as measured by CTC v3.0
time frame: Annually
Neurocognitive toxicity as measured by CTC v3.0
time frame: Years 1, 2 and 5
Male or female participants from 3 years up to 21 years old.
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
|Official title||Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae|
|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 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.|
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