Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649058
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
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:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 11
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 ie 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 11
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 ie cSRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None