Proton Radiation Therapy for Gliomas

Not Applicable

Active, not recruiting

• Conditions: Low Grade Glioma; WHO Grade 3 Glioma With 1p/19q Codeletion; WHO Grade 3 Glioma With IDH1 Mutation
• Interventions: Radiation: Proton radiation

• Registration Number: NCT01358058
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
• Subject must be indicated for radiation therapy
• Life expectancy greater than 5 years
• Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
• Able to speak and comprehend English
• Recovered from adverse events due to agents administered more than 4 weeks before entering study
• Able to undergo MRI scans

Exclusion Criteria

• Prior cranial radiation therapy
• Chemotherapy within 4 weeks prior to entering study
• Pregnant or breastfeeding
• Known brain metastases
• Baseline neurocognitive or emotional disorders
• Uncontrolled intercurrent illness
• History of a different malignancy unless disease-free for at least 5 years
• HIV positive on antiretroviral therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiation therapy	Proton radiation	Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))

Primary Outcome Measures

Name	Time	Method
Efficacy	7 years	To assess progression free survival of this treatment program.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	7 years	To assess the number of participants with late effects from radiation therapy
Overall survival	7 years	To assess overall survival of this treatment program.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States