RecruitingPhase 2NCT06649058

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

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 Systemic Therapy Options


Sponsor

M.D. Anderson Cancer Center

Enrollment

316 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether it is safe and effective to delay local treatment (like surgery or targeted radiation) for brain metastases (cancer that has spread to the brain) and instead start with systemic therapy (medications that travel through the whole body) first, then use precision radiation (SRS) if needed later. **You may be eligible if...** - You are 18 or older with brain metastases - A specialist team (including an oncologist, radiation oncologist, and neurosurgeon) has agreed it is safe to hold off on immediate local brain treatment - Your systemic therapy is expected to have some effect on your brain tumors - Your expected survival is more than 6 months - Your brain metastases could be treated with precision radiation (SRS) if needed **You may NOT be eligible if...** - Your brain metastases require urgent local treatment right away (e.g., causing severe symptoms) - Your overall condition is too poor for the planned therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSystemic Therapy

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

RADIATIONStereotactic Radiosurgery

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


Locations(1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

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NCT06649058


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