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

NCT07655583 | Recruiting Phase 1

• 2 other identifiers: 2026-0345NCI-2026-04559
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastasis; Stereotactic Radiosurgery; Resection; Systemic Therapy

Outcome Measures

Primary Outcomes (1)

• safety and adverse events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

systemic therapy

EXPERIMENTAL

* 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your medical records will continue to be reviewed to look at your health status, unless the participant withdraw or are withdrawn earlier.

Other: Systemic therapy

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.

systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of known leptomeningeal involvement (radiographic or cytological).
• Subjects that have previously received or are currently planned for whole brain radiotherapy.
• Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.
• Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
• Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.
• Pregnancy or plans to become pregnant during the duration of the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas H Beckham, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas H Beckham, MD

CONTACT

(281) 217-2904; thbeckham@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (1)