Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0
Nancy J. Tarbell, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|