A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases
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- STATUS
- Recruiting
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- End date
- Dec 5, 2024
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- participants needed
- 20
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- sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Summary
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.
Description
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.
Details
| Condition | Brain Metastases, Adult |
|---|---|
| Treatment | Pre-operative Stereotactic Radiosurgery |
| Clinical Study Identifier | NCT05341739 |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Last Modified on | 5 May 2022 |
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