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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 October 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: October 16, 2014
Last verified: October 2014

February 1, 2011
October 16, 2014
January 2011
January 2020   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01288235 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
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

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.

- 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Tumor
  • Low Grade Glioma
  • Astrocytoma
  • Ependymoma
  • Ganglioglioma
Radiation: Proton radiotherapy
5 days a week
Experimental: Proton Radiotherapy
Proton Radiotherapy
Intervention: Radiation: Proton radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
January 2020   (final data collection date for primary outcome measure)

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.
Both
1 Year to 25 Years
No
Contact: Torunn I. Yock, MD 617-726-5184 tyock@partners.org
United States
 
NCT01288235
10-206
Yes
Torunn Yock, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)
Principal Investigator: Torunn I. Yock, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP