Overview

This trial is active, not recruiting.

Conditions brain and central nervous system tumors, long-term effects secondary to cancer therapy in children
Treatment radiation therapy
Phase phase 2
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is a single arm study of radiation therapy with protons to standard doses.
radiation therapy
Radiation therapy with proton beam to standard doses

Primary Outcomes

Measure
Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0
time frame: Annually

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.