Pre-Op SRS Before Surgery for Brain Metastases

Recruiting in Palo Alto (17 mi)

Overseen byRodney E Wegner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with solid tumor brain metastases who can consent to treatment, have a Karnofsky Performance Status of ≥70 (meaning they are able to care for themselves), and agree to use contraception. They must be planning surgery for at least one brain metastasis smaller than 5 cm. Those with serious medical or psychiatric illnesses, prior whole-brain radiation, or pregnant women cannot participate.

Inclusion Criteria

My cancer has spread to my brain.

I had a brain MRI less than a month before starting brain SRS.

I am 18 years old or older.

+10 more

Exclusion Criteria

I need assistance with my daily activities.

I have had whole brain radiation therapy or stereotactic radiosurgery on the main tumor.

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

+3 more

Participant Groups

The study tests if performing stereotactic radiosurgery (SRS) before surgical removal of the brain tumor improves chances of complete removal without recurrence and reduces risks like tissue breakdown at the tumor site and leptomeningeal disease development.

1Treatment groups

Experimental Treatment

Group I: Pre-Operative Stereotactic Radiosurgery (SRS)Experimental Treatment1 Intervention

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.