Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

Completed · Not applicable

Conditions studied: Low Grade Gliomas

In brief

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 of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.

Key facts

Study ID

NCT00681473

Run by

Massachusetts General Hospital

People needed

20

Starts

2007-07-01

Expected to finish

2015-08-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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