Status:
ACTIVE_NOT_RECRUITING
A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
Elekta Limited
Conditions:
Brain Metastases, Adult
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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)...
Eligibility Criteria
Inclusion
- Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site
- Solid tumor brain metastases
- Age≥ 18 years
- Karnofsky Performance Status ≥70
- Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis
- Maximum tumor diameter of index lesions \<5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection)
- Brain MRI within 1 month of initiation of brain SRS
- No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases
- Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
- Patient must have the ability to understand and the willingness to sign a written informed consent document
- All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
- Patients receiving prior SRS for brain metastases in other locations of the brain are eligible
- Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated
Exclusion
- Prior WBRT or SRS to the index lesion
- Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter
- Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits.
- Karnofsky Performance Status (KPS) less than (\<)70.
- Patients with absolute contraindication to MRI imaging are not eligible for the study
- Patients who are pregnant are excluded from the study.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05341739
Start Date
December 14 2021
End Date
November 1 2025
Last Update
March 5 2025
Active Locations (1)
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1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212