Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
316
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Evaluation by a brain metastasis multidisciplinary team
- Life expectancy greater than 6 months as estimated by the team
- Agreement that planned systemic therapy may provide intracranial benefit
- Agreement that immediate local therapy is not required
- Brain metastases suitable for stereotactic radiosurgery
- Signed informed consent obtained
- Histologically confirmed metastatic cancer with at least one measurable brain metastasis (5 mm or larger)
- At least one measurable intracranial lesion not previously treated with stereotactic radiosurgery
- Prior surgery or stereotactic radiosurgery allowed if other untreated measurable lesions remain
- Resection cavity treated appropriately or observed for over 6 months without recurrence
- No neurologic symptoms from brain metastases or requiring no more than 2 mg dexamethasone daily
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Agreement by primary medical oncologist on systemic therapy appropriateness
- Non-English speaking subjects allowed with translation support
You will not qualify if you...
- History of leptomeningeal involvement
- Small cell lung cancer, lymphoma, or leukemia histology
- Non-small cell lung cancer with targetable mutation and planned CNS-active targeted therapy
- Prior whole brain radiation therapy
- Any intact brain metastasis larger than 3 cm (unless surgically excised and treated)
- Prior progression on systemic therapy agents planned for use
- Recent (within 30 days) use of systemic therapy agents planned for use
- Prior unacceptable toxicity to systemic therapy agents planned for use
- Major medical, neurologic, or psychiatric conditions preventing study compliance
- History of second malignancy unless treated curatively with no disease for 2 years (exceptions apply)
- Metastatic cutaneous basal or squamous cell carcinoma
- Weight over 450 pounds
- Prior stereotactic radiosurgery within 15 mm of a metastasis
- Inability to undergo brain MRI or use MRI contrast
- Brain metastasis with significant hemorrhagic component (25% or more of lesion size)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Thomas H Bekham, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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