Stereotactic Radiosurgery for Brain Metastasis

Recruiting in Palo Alto (17 mi)

+239 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial compares two radiation treatments for patients with brain cancer that has spread and been surgically removed. One treatment uses a single session of radiation, while the other uses several sessions. The goal is to see which method is more effective and has fewer side effects.

Eligibility Criteria

This trial is for patients with up to three brain metastases from cancer that has spread, but not from germ cell tumors, small cell carcinoma, or lymphoma. Participants must have had one tumor surgically removed within the last 30 days and can't have had whole brain radiation before. They should be able to complete questionnaires in English, Spanish, or French and undergo MRI scans.

Inclusion Criteria

My surgery area is smaller than 5.0 cm and fully removed, confirmed by a recent MRI.

I am fluent in English, Spanish, or French.

My cancer has spread to the protective covering of the brain.

My cancer has not spread to the lining of my brain and spinal cord.

My brain tumor originated from another part of my body.

I can care for myself but cannot do normal activities or work.

I have up to 3 brain tumors that haven't been surgically removed.

My untreated cancer spots are smaller than 4.0 cm on my latest brain MRI.

My brain tumor was larger than 2 cm before surgery.

My brain cancer is not near the optic nerve or brainstem.

I have never had whole brain radiation therapy.

My cancer is not a germ cell tumor, small cell carcinoma, or lymphoma.

Participant Groups

The study compares single-dose stereotactic radiosurgery (a high dose of targeted radiation) with fractionated stereotactic radiosurgery (smaller doses over time) for treating resected brain metastasis. It aims to determine which method is more effective and less harmful to healthy tissue.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (FSRS)Experimental Treatment3 Interventions

Patients undergo FSRS over 3 or 5 daily sessions.

Group II: Arm I (SSRS)Active Control3 Interventions

Patients undergo SSRS over 1 session.