EXCLAIM Study: Brain Metastases and Systemic Therapy

This study, called EXCLAIM, is for people with brain metastases (cancer that has spread to the brain). It's looking at how well standard systemic therapy (treatment that affects the whole body, like chemotherapy or targeted therapy) works first, and then how adding stereotactic radiosurgery (SRS, a type of focused radiation) can help control the cancer in the brain. Researchers want to see if SRS can improve how long the cancer in the brain stays under control, especially for those whose brain metastases respond well to initial systemic therapy, or for those whose brain metastases get worse. You may be eligible if you are 18 or older and have been evaluated by a team of cancer specialists.

Study design
This is a randomized Phase II interventional study, meaning participants will be assigned to different treatment groups by chance. The study plans to enroll 316 participants.
What's involved
Participants will receive systemic therapy as a standard of care option, and some may also receive stereotactic radiosurgery. The study will measure safety and side effects for about one year.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06649058

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~316 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Systemic TherapyStereotactic Radiosurgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs).
Measured over Through study completion; an average of 1 year.
Brain Metastases
1 sites across 1 states
Texas1
  • Thomas H Beckham, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Safety and Adverse Events (AEs).Through study completion; an average of 1 year.

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