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
Recruiting
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Conditions

  • Brain Metastasis
  • Resection
  • Stereotactic Radiosurgery
  • Systemic Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic therapy — OTHER
    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.

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

First listed
Jun 18, 2026
Start date
May 27, 2026
Status verified
Jul 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Thomas H Beckham, MD
[email protected]
281-217-2904
Thomas H Beckham, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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