Proton Radiation Therapy for Gliomas
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
Low Grade Glioma
WHO Grade 3 Glioma With IDH1 Mutation
WHO Grade 3 Glioma With 1p/19q Codeletion
Radiation: Proton radiation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas|
- Efficacy [ Time Frame: 4 years ] [ Designated as safety issue: No ]To assess progression free survival of this treatment program.
- Safety and Tolerability [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]To assess the number of participants with late effects from radiation therapy
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]To assess overall survival of this treatment program.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Proton radiation therapy
Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
Radiation: Proton radiation
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.
Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.
Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam (a limited exam at 6 months, and full exam annually).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358058
|Contact: Barbara Winrich, MAfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Helen A Shih, M.D.|
|Principal Investigator:||Helen A Shih, MD||Massachusetts General Hospital|