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| ID | Type | Description | Link |
|---|---|---|---|
| 1707314702 | Other Identifier | Indiana University IRB |
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This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.
Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Procedure | Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time. Radiosurgery will be performed 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local control of any new, recurrent, or progressing tumors within the planning target volume | Measured by post-treatment MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall survival | Time from start of treatment to death of any cause | 6 months, 1 year, and 2 years |
| Rate of in-brain progression free survival | Time from start of treatment to any in-brain |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Correlation of RNA biomarkers | Correlation of RNA biomarkers with local control | 2 yrs |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Namita Agrawal, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30572923 | Derived | Huff WX, Agrawal N, Shapiro S, Miller J, Kulwin C, Shah M, Savage JJ, Payner T, Vortmeyer A, Watson G, Dey M. Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases: study protocol for a phase II trial. Radiat Oncol. 2018 Dec 20;13(1):252. doi: 10.1186/s13014-018-1178-8. |
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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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| 6 months, 1 year, and 2 years |
| Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume) | Measured by post-treatment MRI | 2 years |
| Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis) | Measured by post-treatment MRI | 2 years |
| Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease) | Measured by post-treatment MRI | 2 years |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | United States |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |