Pilot Study to Avoid Brain Radiation in Adults with Brain Metastases Responding to Systemic Therapy Including Immunotherapy, Targeted Therapy, or Chemotherapy

What this Trial Is About

Researchers are evaluating the possibility of avoiding radiation therapy in patients with brain metastases who respond to systemic treatments like immunotherapy, targeted therapy, or chemotherapy. This pilot pragmatic trial focuses on 45 patients divided into two groups 30 with non-small cell lung cancer NSCLC receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible patients must have at least one brain metastasis not scheduled for radiation or surgery and be starting or planning to start systemic therapy expected to work within the brain. Participants will receive standard systemic therapy expected to reach the brain, such as immunotherapy or targeted agents. A brain MRI will be done 4 to 8 weeks after starting treatment to check the metastases. If the tumors are stable or shrinking, patients will continue on their systemic therapy with brain MRI scans every three months for up to two years. Radiation therapy will only be given if the tumors show progression, based on the treating physicians decision. This approach applies to all participants regardless of their primary cancer type. During the study, participants will undergo regular brain MRI scans and clinical assessments to monitor tumor response and neurological function. Researchers will track outcomes like radiation therapy-free survival at 6 months, intracranial progression, overall survival, radiation necrosis rates, and quality of life using specific questionnaires and scales. The study aims to collect information that will help design future trials and identify patients who might safely avoid brain radiation. The total follow-up for MRI surveillance can last up to two years.

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial