Trial record 1 of 2 for:    "Ganglioglioma"
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Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01288235
First received: February 1, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Brain Tumor
Low Grade Glioma
Astrocytoma
Ependymoma
Ganglioglioma
Radiation: Proton radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Endocrine dysfunction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after radiotherapy.

  • Neurocognitive sequelae [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.


Secondary Outcome Measures:
  • Disease control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To report the 3 year and 5 year local and distant disease control

  • Acute effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To assess the acute effects of treatment including hair loss in the portal.

  • Auditory function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To correlate dose to the cochlea to auditory function.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy
Proton Radiotherapy
Radiation: Proton radiotherapy
5 days a week

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.

  Eligibility

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288235

Contacts
Contact: Torunn I. Yock, MD 617-726-5184 tyock@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Torunn Yock, M.D.       tyock@partners.org   
Principal Investigator: Torunn I. Yock, MD         
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Karen Marcus, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Torunn I. Yock, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01288235     History of Changes
Other Study ID Numbers: 10-206
Study First Received: February 1, 2011
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton radiotherapy

Additional relevant MeSH terms:
Ganglioglioma
Astrocytoma
Brain Neoplasms
Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014