Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Status: | Active, not recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/11/2016 |
Start Date: | July 2007 |
End Date: | August 2016 |
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.
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.
- 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.
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.
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
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