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This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery to 2 mm GTV to PTV margins | Active Comparator |
| |
| Stereotactic Radiosurgery to 0 mm GTV to PTV margins | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Procedure | The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months | Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) rates estimated by the Kaplan-Meier method | Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm, and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robyn Hseu | Contact | 773-834-3198 | rhseu@radonc.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Steven J. Chmura, M.D., Ph.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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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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| Overall survival rates |
Time from Stereotactic Radiosurgery (SRS) completion to death. |
| 2 years |
| Rates of radiation necrosis | To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation necrosis. | 2 years |
| Rates of pseudoprogression | To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation pseudoprogression. | 2 years |
| Local failure rates | Local failure and OS rates at 6 months, 1 year and 2 years will be estimated by the Kaplan-Meier method, comparing arms via the log-rank statistic. | 2 years |
| Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities | Any acute CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities, within 90 days of SRS completion (toxicity must be specified). | 90 days |
| Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities | To compare rates of late (greater than 90 days from SRS) CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities. | 2 years |
| Rates of distant intracranial failure | The appearance of new non-target lesions ≥5 mm following completion of radiotherapy will be considered distant intracranial failure. If a non-target lesion <5 mm is found on a later scan to have increased to ≥ 5 mm, distant intracranial failure will be declared at the date of the earliest scan showing the new lesion. | 2 years |
| Rates of salvage therapy | Time to initiation of any combination of salvage Stereotactic Radiosurgery (SRS), Whole Brain Radiation Therapy WBRT, or neurosurgical resection for intracranial failure. | 2 years |
| Association between dose and risk of radionecrosis or pseudoprogression | To determine association between V10Gy and V12Gy all tissue, whole brain and normal brain parameters and risk of radionecrosis or pseudoprogression. | 2 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |