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
M.D. Anderson Cancer Center
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.
Description
Primary Objectives: To assess whether cSRS improves CNS progression-free survival (CNS-PFS) in patients with BM who have a PR or SD with upfront systemic therapy. To assess whether SRS to all BM not in CR (cSRS + pdSRS) versus only progressing lesions (pdSRS) improves CNS-PFS in patients with CNS progression on upfront systemic therapy. Secondary Objectives: To report the rate and degree of response of BM to systemic therapy by specific regimen and histology. To report adverse neurologic events that occur with BM treated with upfront systemic therapy and differences in these events betwee…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon. This evaluation can take place in clinic or during a multidisciplinary conference. 3. Life expectancy \> 6 months as estimated by BM-MDT. 4. BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS). 5. BM-MDT agreement that the patient's BM does not require immediate local…
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
Location
- The University of Texas MD Anderson Cancer CenterHouston, Texas