Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
- Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday
through Friday, for a total of 30 treatments.
- A medical history and physical examination will be performed prior to the start of
radiation treatment, weekly during the 6 weeks of radiation and after the finish of
radiation performed at 3 and 6 months and then annually for 5 years.
- Hormonal function tests will be taken prior to the start of radiation treatment and
after the finish of radiation treatment at 3 and 6 months, and annually for five years
to assess the participants hormonal functions as they relate to the pituitary gland's
function.
- A brain MRI will be performed prior to the start of radiation treatment and then
performed at 3 and 6 months after radiation treatment then annually for 5 years.
- A neurocognitive exam will be performed prior to the start of radiation therapy, a
limited exam 6 months after the completion of radiation therapy, and a complete exam
annually for 5 years.
- Quality of Life and Emotional Well-Being Questionnaires will be done before radiation
begins, 2 months after radiation treatment, 6 months after radiation treatment and then
annually for 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To characterize radiation late effects in low-grade glioma patients treated with proton radiation therapy.
5 years
Yes
Helen A. Shih, MD, MS, MPH
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
06-195
NCT00681473
July 2007
July 2013
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |