Combined Gamma KnifeLinac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs GK-LIVE A Prospective Phase II Single-Arm Trial

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with large brain tumors or brain metastases using a combination of two types of precise radiation therapy machines the linear accelerator and the Gamma Knife. This study aims to see if combining these technologies can improve tumor control and reduce side effects compared to the current standard treatment, which uses only the linear accelerator. The researchers believe that the break between treatments and the unique qualities of each machine may help protect healthy brain tissue better and control the tumor more effectively. The treatment plan involves first giving patients four daily radiation treatments with the linear accelerator. After these treatments, there is a 1-2 week break during which new scans are taken to assess tumor shrinkage and better target any remaining tumor areas. The final treatment is then delivered using the Gamma Knife, which provides very precise radiation to the tumor while sparing healthy tissue. This combined approach is being studied in a prospective, single-arm Phase II trial. Participants will be monitored closely throughout the study and for up to 24 months after treatment. Researchers will assess the safety and effectiveness of the combined therapy by measuring late local complications, tumor control, survival, brain progression, radiation side effects, neurological function, and quality of life. Regular imaging scans and clinical evaluations will be done to track outcomes and side effects. The total study duration includes treatment and long-term follow-up to understand the benefits and risks of this new treatment strategy.

Combined Gamma Knife/Linac Radiosurgery for Large Brain Tumors / Metastases