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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06649058
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic Therapy — OTHER
    Participants will receive systemic therapy as a standard of care therapeutic option
  • Stereotactic Radiosurgery — RADIATION
    Participants will receive systemic therapy as a standard of care therapeutic option

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cSRS PR or SD
    Patients with a CR will be observed with ongoing standard of care MRI. Patients with SD or PR will be randomized to receive cSRS or ongoing observation.
  • Experimental: a-pdSR CNS PD
    At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.
  • Experimental: b-PDC CNS PD
    At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.
  • Experimental: SST treated SD or PR patients to receive cSRS/ ongoing observation
    Patients with a CR will be observed with ongoing standard of care MRI. Patients with SD or PR will be randomized to receive cSRS or ongoing observation.
  • Experimental: SST treated PD patients to pdSRS / pdSRS+cSRS
    At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.

Primary Outcome Measure

Safety and Adverse Events (AEs). [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Thomas H Beckham, MD,PHD
[email protected]
713-825-3169
Thomas H Beckham, MD,PHD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas MD Anderson Cancer Center· Houston, TX

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