Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma|
- To characterize radiation late effects in low-grade glioma patients treated with proton radiation therapy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To document progression free survival rates by proton radiation in patients with low-grade gliomas. [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Proton Radiation Therapy
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
Radiation: Proton Radiation Therapy
Once daily, Monday through Friday, for 6 weeks.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681473
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Helen A. Shih, MD, MS, MPH||Massachusetts General Hospital|