Status:
COMPLETED
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Low Grade Gliomas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response...
Detailed Description
* Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday through Friday, for a total of 30 treatments. * A medical history and physical examination will be performed pri...
Eligibility Criteria
Inclusion
- Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
- Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
- KPS of 70 or greater
- 18 years of age or older
- Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
- Must be able to speak and comprehend English
Exclusion
- Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
- Prior history of cranial irradiation
- Pregnancy at the time of radiation treatment
- Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
- Comorbid illness or reason to suggest a life expectancy of less than 5 years
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00681473
Start Date
July 1 2007
End Date
August 1 2015
Last Update
March 7 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114