OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT07655583
- Status
- Suspended
Conditions
- Brain Metastasis
- Resection
- Stereotactic Radiosurgery
- Systemic Therapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Systemic therapy — OTHERSystemic 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.
Study Details
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.
Key Dates
- Start date
- May 27, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 20 participants (estimated)
Arms
- Arm: systemic therapy
Primary Outcome Measure
safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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