Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01288235
• Collaborator: Dana-Farber Cancer Institute (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 139
• Patients Per Site: 50
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor; Low Grade Glioma; Astrocytoma; Ependymoma; Ganglioglioma	Radiation: Proton radiotherapy	Phase 2

Detailed Description

• Participants will receive proton radiotherapy at the Francis H. Burr Proton Therapy Center which is located at the Massachusetts General Hospital. They will receive the proton radiotherapy 5 days per week. The number of weeks the participant will be receiving proton radiotherapy depends upon the tumor type and location and how well they are tolerating the treatment. Participant's will have a physical exam weekly during proton radiotherapy treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation: An Assessment of Long Term Neurocognitive, Neuroendocrine Adn Ototoxicity Outcomes
• Actual Study Start Date: Feb 1, 2011
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proton Radiotherapy Proton Radiotherapy	Radiation: Proton radiotherapy; 5 days a week

Outcome Measures

Primary Outcome Measures

1. Endocrine dysfunction [5 years]

   To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after radiotherapy.

2. Neurocognitive sequelae [5 years]

   To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.

Secondary Outcome Measures

1. Disease control [5 years]

   To report the 3 year and 5 year local and distant disease control

2. Acute effects [5 years]

   To assess the acute effects of treatment including hair loss in the portal.

3. Auditory function [5 years]

   To correlate dose to the cochlea to auditory function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma, meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor requiring tumor bed or tumor irradiation. Patients with a presumed diagnosis of optic glioma or gliomas based on imaging and clinical characteristics will also be allowed on this trial.

• Patients with biopsy proven high grade glioma (excluding GBM) and a gross total resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) may also be included.

• Pathologic diagnosis must be based on pathology or pathology review by Department of Pathology at MGH or another DF/HCC institution.

• Age between 1-25 years.

• Life expectancy of greater than 1 year.

• ECOG Performance Status 0, 1, 2 or 3 or Lansky performance status 30 or greater.

• Girls and women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

• Participants who have had radiotherapy to the site to be treated.

• Participants with known spinal or distant metastases. Patients with ependymoma, medulloblastoma or germinoma must have metastatic workup including spine MRI to rule out metastases.

• Uncontrolled intercurrent illness that would limit compliance with study requirements.

• Pregnant or breastfeeding women.

• Patients who cannot participate in contributing to the neurocognitive outcomes due to severe neurologic impairment or language barrier (ie not English or Spanish speaking) will be excluded from this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Massachusetts General Hospital
• Dana-Farber Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Torunn I. Yock, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01288235
• Other Study ID Numbers: 10-206
• First Posted: Feb 2, 2011
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital: proton radiotherapy
• Additional relevant MeSH terms: Brain Neoplasms; Astrocytoma; Ependymoma; Ganglioglioma

Study Results

No Results Posted as of Oct 4, 2021