Low Grade Gliomas Clinical Trial
Official title:
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
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.
- 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00517959 -
SCRT Versus Conventional RT in Children and Young Adults With Low Grade and Benign Brain Tumors
|
Phase 3 |