OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy

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

Sep 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2030

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: systemic therapy
  * Begin CNS active systemic therapy as recommended by your oncologist within 5 weeks after surgery. * Attend study visits every 12 weeks during Years 1 and 2. * Participate in 4 neurocognitive function assessments in specific windows of time. * Beyond 2 years, your medical records will continue to be reviewed to look at your health status, unless the participant withdraw or are withdrawn earlier.

Primary Outcome Measure

safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Thomas H Beckham, MD
  (281) 217-2904
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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