A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

  • End date
    Dec 5, 2024
  • participants needed
  • sponsor
    Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Updated on 5 May 2022


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.

Condition Brain Metastases, Adult
Treatment Pre-operative Stereotactic Radiosurgery
Clinical Study IdentifierNCT05341739
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Last Modified on5 May 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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