Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

NCT01288235 | Completed Phase 2 Results DMC

• 1 other identifier: 10-206
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Tumor; Low Grade Glioma; Astrocytoma; Ependymoma; Ganglioglioma

Keywords

proton radiotherapy

Outcome Measures

Primary Outcomes (2)

• Endocrine Dysfunction

  Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

  3- and 5- years post radiation treatment

• Neurocognitive Sequelae

  The overall change in neurocognitive outcomes between treatment and last-follow-up as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full-Scale Intelligence Quotient (FSIQ) of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence.

  From the start of radiation treatment (baseline) to study completion. Participants were assessed annually up to 5 years following treatment completion. The median follow-up is 4.7 years.

Secondary Outcomes (3)

• Disease Control

  3- and 5- years post radiation treatment

• Cumulative Incidence of Grade 3+ Toxicities

  3- and 5- years post radiation treatment

• Cumulative Incidence of Ototoxicity

  3- and 5- years post radiation treatment

Study Arms (1)

Proton Radiotherapy

EXPERIMENTAL

Proton Radiotherapy

Radiation: Proton radiotherapy

Interventions

Proton radiotherapy RADIATION

5 days a week

Proton Radiotherapy

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Vatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17.

  PMID: 30118397 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Astrocytoma; Ependymoma; Ganglioglioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Torunn I. Yock, MD
• Organization: Massachusetts General, Hospital

tyock@mgh.harvard.edu

6177262000

Study Officials

• Torunn I. Yock, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Radiation Oncology

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-06

Locations

US (2)