MedTrace Logo

EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active

NCT06649058 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-04-15

No results posted yet for this study

Summary

To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy.

To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.

Conditions

Interventions

OTHER

Systemic Therapy

Participants will receive systemic therapy as a standard of care therapeutic option

RADIATION

Stereotactic Radiosurgery

Participants will receive systemic therapy as a standard of care therapeutic option

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Thomas H Beckham, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2028-09-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649058 on ClinicalTrials.gov