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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05337 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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no enrollment
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This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectable). Stereotactic radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor, and may cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the return of brain metastases less likely and help patients live longer compared to surgery followed by radiation therapy.
PRIMARY OBJECTIVE:
I. To determine the rate of leptomeningeal failure after neoadjuvant radiation therapy (NaRT) versus (vs) postoperative stereotactic radiosurgery (SRS)/stereotactic radiation therapy (SRT).
SECONDARY OBJECTIVES:
I. Local control of brain metastases. II. Rate of salvage treatment including surgery, SRS, SRT, or whole brain radiation therapy (WBRT).
III. Dose and volume of radiation to adjacent normal brain parenchyma. IV. Rate of symptomatic radiation necrosis/steroid dependency. V. Rate of distant brain failure. VI. To compare overall survival (OS) between the 2 groups. VII. To determine the number of patients who die due to neurologic causes. VIII. To assess quality of life as assessed using Functional Assessment of Cancer Therapy?Brain (FACT?BR).
IX. To evaluate and compare the molecular makeup of tumor tissue in pre vs post radiation settings and determine differences in molecular and germline markers.
X. To evaluate biomarkers and germline markers predicting response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
ARM B: Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
After completion of study treatment, patients are followed up every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (SRS/SRT, surgery) | Experimental | Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy. |
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| Arm B (surgery, SRS/SRT) | Active Comparator | Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of leptomeningeal failure | A two-sided Z test with pooled variance will be used at significance level =0.1 to test if there is a difference in leptomeningeal failure rate between the two treatment groups. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Local control of brain metastases is defined as tumor has not progressed or recurred with no radiographic or symptomatic progression. Using the Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases, progressive disease will be defined as > 20% increase in the sum of the longest diameters of the target lesions; unequivocal progression of enhancing non?target lesions; new lesions; or substantial clinical decline. Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tania B Kaprealian, MD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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| Stereotactic Radiosurgery | Radiation | Undergo SRS/SRT |
|
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| Therapeutic Conventional Surgery | Procedure | Undergo standard of care surgery |
|
| Up to 2 years |
| Rate of salvage treatment including surgery, SRS, SRT, or WBRT | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| Dose (Gy) and volume (cc) of radiation to adjacent normal brain parenchyma | Will be compared using t test for continuous outcomes, log rank test for time-to-event outcomes and Z test for binary outcomes. | Up to 2 years |
| Rate of symptomatic radiation necrosis/steroid dependency | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| Rate of distant brain failure | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| Overall survival (OS) | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| Death due to neurological causes | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| Quality of life assessment: FACTBR | Assessed using Functional Assessment of Cancer Therapy-Brain (FACTBR). Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. The scale is 0 - 4, 0 = "not at all", 4 = "very much". Overall higher ratings mean higher quality of life. | Up to 2 years |
| Genetic expression profiles in pre vs post radiation tumor tissue | Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. | Up to 2 years |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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