NCT01358058

Proton Radiation Therapy for Gliomas

Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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, MRI, 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 annually.

Conditions

• Low Grade Glioma
• WHO Grade 3 Glioma With IDH1 Mutation
• WHO Grade 3 Glioma With 1p/19q Codeletion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2011-05-23
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States