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Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Primary Purpose

Brain Tumor, Low Grade Glioma, Astrocytoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Proton radiotherapy

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring proton radiotherapy

Eligibility Criteria

1 Year - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiotherapy

Arm Description

Proton Radiotherapy

Outcomes

Primary Outcome Measures

Endocrine dysfunction

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

Neurocognitive sequelae

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

Secondary Outcome Measures

Disease control

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

Acute effects

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

Auditory function

To correlate dose to the cochlea to auditory function.

Full Information

NCT ID

NCT01288235

First Posted

February 1, 2011

Last Updated

January 5, 2023

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01288235

Brief Title

Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2011 (Actual)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

proton radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiotherapy

Arm Type

Experimental

Arm Description

Proton Radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Proton radiotherapy

Intervention Description

5 days a week

Primary Outcome Measure Information:

Title

Endocrine dysfunction

Description

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

Time Frame

5 years

Title

Neurocognitive sequelae

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Disease control

Description

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

Time Frame

5 years

Title

Acute effects

Description

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

Time Frame

5 years

Title

Auditory function

Description

To correlate dose to the cochlea to auditory function.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torunn I. Yock, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30118397

Citation

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.

Results Reference

derived

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Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

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