Description:
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.
Title
- Brief Title: Proton Radiation Therapy for Gliomas
- Official Title: Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
Clinical Trial IDs
- ORG STUDY ID:
10-439
- NCT ID:
NCT01358058
Conditions
- Low Grade Glioma
- WHO Grade 3 Glioma With IDH1 Mutation
- WHO Grade 3 Glioma With 1p/19q Codeletion
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Proton radiation therapy | Experimental | Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE)) | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Efficacy |
| Time Frame: | 7 years |
| Safety Issue: | |
| Description: | To assess progression free survival of this treatment program. |
Secondary Outcome Measures
| Measure: | Safety and Tolerability |
| Time Frame: | 7 years |
| Safety Issue: | |
| Description: | To assess the number of participants with late effects from radiation therapy |
| Measure: | Overall survival |
| Time Frame: | 7 years |
| Safety Issue: | |
| Description: | To assess overall survival of this treatment program. |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Massachusetts General Hospital |
Trial Keywords
- Brain tumors
- Radiation
- Proton
- Gliomas
Last Updated
August 18, 2020
