Clinical Trial: Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: - 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.
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• Endocrine dysfunction [ Time Frame: 5 years ]
  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 ]
  To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Disease control [ Time Frame: 5 years ]
  To report the 3 year and 5 year local and distant disease control
• Acute effects [ Time Frame: 5 years ]
  To assess the acute effects of treatment including hair loss in the portal.
• Auditory function [ Time Frame: 5 years ]
  To correlate dose to the cochlea to auditory function.

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: February 1, 2011
Date Started: January 2011
Date Completion: January 2020
Last Updated: March 2, 2017
Last Verified: March 2017