Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01288235
• Other study ID #: 10-206
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: September 2025

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astrocytoma
• Brain Neoplasms
• Brain Tumor
• Ependymoma
• Ganglioglioma
• Low Grade Glioma

Intervention

Radiation:
• Proton radiotherapy
5 days a week

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocrine dysfunction	To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after radiotherapy.	5 years
Primary	Neurocognitive sequelae	To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.	5 years
Secondary	Disease control	To report the 3 year and 5 year local and distant disease control	5 years
Secondary	Acute effects	To assess the acute effects of treatment including hair loss in the portal.	5 years
Secondary	Auditory function	To correlate dose to the cochlea to auditory function.	5 years