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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04737 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Primary Objective:
To determine whether SRS2 following surgery/LITT for patients with recurrent previously irradiated brain metastases improves time to local recurrence compared to close surveillance following surgery/LITT.
To summarize time to local recurrence for patients with recurrent previously irradiated brain metastases receiving SRS2 due to being ineligible for surgery/LITT.
Secondary Objectives:
To test if the effect of SRS2 versus surveillance after LITT or surgery in patients with recurrent previously irradiated brain metastases is associated with the type of surgical intervention.
To determine whether SRS2 versus close surveillance following surgery/LITT for recurrent previously irradiated brain metastases improves distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival.
To summarize distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival for patients receiving SRS2 alone for recurrent, previously irradiated brain metastases.
To summarize patient-reported outcomes including neurocognitive symptoms, functional independence, and quality of life for patients who receive SRS2 for recurrent, previously irradiated brain metastases.
To summarize radionecrosis and adverse event rates for patients who receive SRS2 following surgery/LITT for recurrent previously irradiated brain metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible for surgery or LITT-Surveillance | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
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| Eligible for surgery or LITT-SRS2 | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
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| Ineligible for surgery or LITT-SRS2 | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Participants will initially undergo craniotomy and surgical resection of lesions or LITT |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subha Perni, MD | Contact | 713-563-2543 | sperni@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Subha Perni, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| LITT | Procedure | Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise. |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |