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| Name | Class |
|---|---|
| Elekta Limited | INDUSTRY |
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This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.
Patients with a solid tumor malignancy that has metastasized to the brain are invited to participate in this trial. Upon enrollment to this study a subject will undergo stereotactic radiosurgery (SRS) using the Elekta Gamma Knife Icon, being treated in once daily 15 minute fractions of 9 Gray (Gy) or every other day 15 minute fractions of 9 Gy for a total dose of 27 Gy in 3 doses. A subject will undergo a routine CT and MRI simulation to determine positioning of the head prior to the start of the SRS treatment. Within two (2) weeks after completion of SRS a subject will undergo a routine surgical resection of the brain metastasis. Prior to the SRS treatment and during the follow up phase of the study MRIs will be performed, which are standard of care. Subjects will also complete a quality of life questionnaire. The duration of subject's time participating in this study is 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Operative Stereotactic Radiosurgery (SRS) | Experimental | Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative Stereotactic Radiosurgery | Other | Pre-operative SRS will be performed prior to the surgical resection of the brain metastases. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Local Control | Radiographic local control at 1 year following completion of pre-operative SRS followed by surgical resection of brain metastasis. Local control will be according to the Response Assessment criteria for Neuro-Oncology (RANO) for brain metastases. | 4-5 Years from first subject enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Leptomeningeal disease | MRI will be utilized to evaluate for evidence of leptomeningeal spread at 3 month intervals following preoperative SRS followed by surgical resection of the brain metastasis. | 4-5 years from first subject enrolled. |
| Radio-Necrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney E Wegner, MD | AHN Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | 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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Pathologic confirmation of radio-necrosis will be recorded as binary variable for each patients as well as the date of surgery confirming radio-necrosis, as applicable. |
| 4-5 years from first subject enrolled |
| Pseudo-Progression | Defined as worsening T1 post-gadolinium contrast enhancement and fluid attenuated inversion recovery (FLAIR) changes following SRS which resolve independently without any intervention beyond steroids. | 4-5 years from first subject enrolled |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |