Preoperative Stereotactic Radiosurgery for Brain Metastases

Recruiting in Palo Alto (17 mi)

Overseen byMichael Yu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.

Eligibility Criteria

This trial is for adults with certain solid tumor cancers that have spread to the brain, and are expected to live at least 3 more months. They must have one or more brain tumors suitable for surgery and not previously treated with specific radiosurgery. Participants should be able to undergo MRI scans, not be pregnant or breastfeeding, and willing to use effective contraception.

Inclusion Criteria

I am allowed to receive treatments like immunotherapy or chemotherapy as decided by my doctor.

This study permits the re-enrollment of participant who has discontinued the study due to pre-treatment failure (i.e., the participant has not been treated). If re-enrolled, participant must be re-consented

I can care for myself but may need occasional help.

+8 more

Exclusion Criteria

Individuals who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

My brain cancer is near the optic nerve.

Participants with active or prior documented inherited hypersensitivity syndromes, certain collagen vascular diseases, and certain autoimmune diseases

+14 more

Participant Groups

The study tests if pre-operative hypofractionated stereotactic radiosurgery (a type of focused radiation therapy) followed by surgery can extend the time before a brain tumor starts growing again compared to current treatments.

1Treatment groups

Experimental Treatment

Group I: Hypofractionated Stereotactic Radiosurgery prior to resectionExperimental Treatment1 Intervention

Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected on Days 1-3 (3 consecutive days). If there are additional non index brain metastasis, they will be treated with standard stereotactic radiosurgery at the time of fSRS. Participants will then undergo stereotactic craniotomy for surgical resection of the index metastasis within 5 days following completion of fSRS.