- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358058
Proton Radiation Therapy for Gliomas
Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proton radiation therapy
Single arm study delivering fractionated proton therapy over 6 week (54-59.4
Gy(RBE))
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 7 years
|
To assess progression free survival of this treatment program.
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability
Time Frame: 7 years
|
To assess the number of participants with late effects from radiation therapy
|
7 years
|
Overall survival
Time Frame: 7 years
|
To assess overall survival of this treatment program.
|
7 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helen A Shih, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-439
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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