Clinical Trial Title
Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS with Brain Metastasis Velocity >/= 4 Brain Metastases/YearNational Clinical Trial Number:
NCT04588246Contact Information
Clinical Trial Protocol Description:
This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on thinking and memory. Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in shrinking or stabilizing cancer that has spread to the brain and returned in other areas of the brain after receiving stereotactic radiosurgery.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have developed first or second distant brain relapse(s) at least 8 weeks after upfront SRS.
- Have brain metastasis velocity (BMV) since upfront SRS.
- Have pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma, or gastrointestinal cancer within 10 years prior to randomization.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior WBRT or prophylactic cranial irradiation.
- Have had local relapse of metastasis previously treated with upfront SRS.
- Have brain metastases from primary germ cell tumor, small cell carcinoma, or lymphoma.
- Have definitive leptomeningeal metastasis.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.