Trial Information

Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae

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.