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Clinical Trials | Single Fraction Stereotactic Radiosurgery (SRS) vs. Fractionated SRS (FSRS) for Brain Metastases

NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES

The UVA Department of Neuro-Oncology seeks adults age 18 and older with unresected (not surgically removed) brain metastases for a research study. The purpose of this study is to determine whether delivering Stereotactic Radiosurgery in three treatments (FSRS) delays or prevents tumor regrowth longer than delivering the radiation in a single treatment (SRS). Stereotactic Radiosurgery (SRS), is a highly precise, non-invasive cancer therapy that delivers high-dose radiation to small, well-defined tumors and is the current standard of treatment for many patients with brain metastases. This type of treatment helps preserve memory and thinking ability compared to whole brain radiation. However, research studies have shown that when a tumor is treated with a single session of SRS, the chance of tumor regrowth gradually increases over time. Delivering the radiation in three smaller treatments may prevent the tumor from growing while still protecting brain function and quality of life. This study will compare the standard one-day treatment against a three-day treatment to determine which one delays tumor regrowth for a longer period of time. You may be eligible for this study if you: • Are 18 years of age or older • Have been diagnosed with certain cancers (such as lung cancer, breast cancer, melanoma, kidney cancer, or gastrointestinal cancer) that have spread to the brain • Have 1 to 8 brain tumors that have not been surgically removed and are appropriate for stereotactic radiosurgery treatment • Have not received prior radiation treatment to the brain Study involves: • An MRI scan of the brain for treatment planning • Randomized assignment to receive stereotactic radiosurgery in one session or three sessions given over several days • Outpatient stereotactic radiosurgery (no overnight hospital stay required) • Follow-up MRI scans and clinic visits to monitor tumor response and side effects Radiation treatment will begin within about 1-2 weeks after enrollment. • If assigned to the one-day treatment, stereotactic radiosurgery is delivered in a single visit • If assigned to the three-day treatment, stereotactic radiosurgery is delivered over 3-5 consecutive days Each treatment visit may last several hours. After treatment, participants will have regular follow-up visits every few months, which include MRI scans and clinic visits to monitor the tumor and overall health. Participant’s insurance company will be billed for medication, tests and procedures. For more information, please email: [email protected] or 434-243-7336