Proton Radiation Therapy for Gliomas

Status: Recruiting
Phase: Phase 2
Diagnosis: Radiation Oncology
NCT ID: NCT01358058 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-439

 

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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Helen Shih, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed low-grade gliomas - 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
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