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

Not Applicable

Completed

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 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.

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 prior to the start of radiation treatment, weekly during the 6 weeks of radiation and after the finish of radiation performed at 3 and 6 months and then annually for 5 years.

* Hormonal function tests will be taken prior to the start of radiation treatment and after the finish of radiation treatment at 3 and 6 months, and annually for five years to assess the participants hormonal functions as they relate to the pituitary gland's function.

* A brain MRI will be performed prior to the start of radiation treatment and then performed at 3 and 6 months after radiation treatment then annually for 5 years.

* A neurocognitive exam will be performed prior to the start of radiation therapy, a limited exam 6 months after the completion of radiation therapy, and a complete exam annually for 5 years.

* Quality of Life and Emotional Well-Being Questionnaires will be done before radiation begins, 2 months after radiation treatment, 6 months after radiation treatment and then annually for 5 years.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Proton Radiation Therapy	Proton Radiation Therapy	Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Late Effects > 3 Months Post RT	5 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Progression Free Survival	At 1, 3, and 5 years	Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
Percentage of Participants With Overall Survival	At 1, 3, and 5 years	Percentages were estimated by Kaplan Meier