Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT06649058
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2024-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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 Systemic Therapy Options
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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 between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To evaluate rates of LMD in all patients managed with upfront systemic therapy and differences in LMD rates between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To evaluate neurocognitive changes in patients treated with upfront systemic therapy for BMand differences in these changes between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To perform inference on overall survival as estimated by the Kaplan-Meier estimator in patients treated with upfront systemic therapy for BM and differences in these changes between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
Exploratory Objectives:
To correlate imaging biomarkers with outcomes of BM treated with systemic therapy.
To correlate volumetric assessment of lesion response to conventional assessment by mRECIST 1.1.
To explore ML as a tool to predict outcomes of BM treatment based on disease specific, clinical, and lesion specific features.
To explore the association of circulating bioanalytes with up front systemic therapy for BM and subsequent downstream management strategies (i.e. cSRS).
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 between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To evaluate rates of LMD in all patients managed with upfront systemic therapy and differences in LMD rates between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To evaluate neurocognitive changes in patients treated with upfront systemic therapy for BMand differences in these changes between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
To perform inference on overall survival as estimated by the Kaplan-Meier estimator in patients treated with upfront systemic therapy for BM and differences in these changes between various downstream radiation therapy options (omission, cSRS, pdSRS, etc).
Exploratory Objectives:
To correlate imaging biomarkers with outcomes of BM treated with systemic therapy.
To correlate volumetric assessment of lesion response to conventional assessment by mRECIST 1.1.
To explore ML as a tool to predict outcomes of BM treatment based on disease specific, clinical, and lesion specific features.
To explore the association of circulating bioanalytes with up front systemic therapy for BM and subsequent downstream management strategies (i.e. cSRS).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-08780 | OTHER | NCI-CTRP Clinical Trials Registry | View |