Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
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.
Brain and Central Nervous System Tumors
Long-term Effects Secondary to Cancer Therapy in Children
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Neuroendocrine toxicity as measured by CTC v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Neurocognitive toxicity as measured by CTC v3.0 [ Time Frame: Years 1, 2 and 5 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Radiation therapy
This is a single arm study of radiation therapy with protons to standard doses.
Radiation: radiation therapy
Radiation therapy with proton beam to standard doses
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105560
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Study Chair:||Nancy J. Tarbell, MD||Massachusetts General Hospital|