Proton Radiation Therapy for Gliomas

Low Grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01358058
• Other study ID #: 10-439
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	To assess progression free survival of this treatment program.	7 years
Secondary	Safety and Tolerability	To assess the number of participants with late effects from radiation therapy	7 years
Secondary	Overall survival	To assess overall survival of this treatment program.	7 years