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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site. 2. Solid tumor brain metastases. 3. Age≥ 18 years. 4. Karnofsky Performance Status ≥70. 5. Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis. 6. Maximum tumor diameter of index lesions <5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection) 7. Brain MRI within 1 month of initiation of brain SRS. 8. No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases. 9. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child. 10. Patient must have the ability to understand and the willingness to sign a written informed consent document. 11. 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. 12. Patients receiving prior SRS for brain metastases in other locations of the brain are eligible. 13. Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated.

Exclusion Criteria:

1. Prior WBRT or SRS to the index lesion. 2. Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter. 3. 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. 4. Karnofsky Performance Status (KPS) less than (<)70. 5. Patients with absolute contraindication to MRI imaging are not eligible for the study. 6. Patients who are pregnant are excluded from the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05341739
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rodney E Wegner, MD
Principal Investigator Affiliation	AHN Radiation Oncology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Adult

Additional Details

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.

Arms & Interventions

Arms

Experimental: Pre-Operative Stereotactic Radiosurgery (SRS)

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.

Interventions

Other: - Pre-operative Stereotactic Radiosurgery

Pre-operative SRS will be performed prior to the surgical resection of the brain metastases.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Site Contact

Clinical Trials Contact

[email protected]

412-330-6151