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The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Stereotactic Radiosurgery prior to resection | Experimental | Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected on Days 1-3 (3 consecutive days). If there are additional non index brain metastasis, they will be treated with standard stereotactic radiosurgery at the time of fSRS. Participants will then undergo stereotactic craniotomy for surgical resection of the index metastasis within 5 days following completion of fSRS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Stereotactic Radiosurgery | Radiation | Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from surgery until Intracranial Progression | Time from surgery until first occurrence of Intracranial Progression or death. If none of these events occur, patients will be censored on date of last contact. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from surgery to death, censoring at the last contact date if no deaths. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Local control rate is defined as the freedom from local progression | at 6 months |
| Local Control Rate | Local control rate is defined as the freedom from local progression |
Inclusion Criteria:
Exclusion Criteria:
Widespread definitive leptomeningeal metastasis Infratentorial mass effect with fourth ventricle effacement or hydrocephalus Supratentorial mass effect with greater than 10 mm of midline shift or hydrocephalus.
A brain metastasis that is located within 2 mm of the optic chiasm
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| Name | Affiliation | Role |
|---|---|---|
| Michael Yu, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 |
| 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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| at 12 months |
| Rate of Leptomeningeal Disease (LMD) | Rate of LMD is defined as the percentage of participants that progressed to leptomeningeal disease | at 12 months |
| Rate of distant brain recurrence (DBR) | Rate of distant brain recurrence defined as the percentage of participants that experienced distant brain recurrence | at 12 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |