OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy
M.D. Anderson Cancer Center
Summary
To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.
Description
Primary Objective To estimate the risk of surgical bed recurrence of resected melanoma or NSCLC brain metastases treated with highly CNS-active systemic therapy without post-operative radiation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. Age ≥ 18 years. 2. ECOG performance status ≤ 2. 3. Participants with a resected brain metastasis with gross total resection and pathologic confirmation of NSCLC or melanoma. Gross total resection must be confirmed based on a review of the operative report, pathology, and all post-operative images available at the time of enrollment. 4. Brain metastasis resection occurred ≤ 5 weeks ago. 5. Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is co…
Interventions
- OtherSystemic therapy
Systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC.
Location
- MD Anderson Cancer CenterHouston, Texas