Stereotactic Radiosurgery for Brain Cancer

Palo Alto (17 mi)

Overseen byDebra NAna Yeboa

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Eligibility Criteria

This trial is for patients over 3 years old with brain metastases who've had surgery to remove at least one tumor. They must have a good performance status, be able to undergo an MRI, and can't have had previous brain radiation or certain cancers like small-cell lung cancer. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

I can care for myself but may not be able to do active work or play.

I am older than 3 years.

My brain tumors are no larger than 3 cm.

I have up to 3 new brain metastases and had surgery to remove one.

Exclusion Criteria

My primary cancer is either small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.

I have had radiation therapy to my brain before.

Treatment Details

The study compares stereotactic radiosurgery (SRS)—a precise form of radiation therapy—with just watching the patient after they've had surgery for brain tumors. The goal is to see if SRS offers better outcomes than not treating further.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (SRS)Experimental Treatment1 Intervention

Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.

Group II: Arm II (observation)Active Control1 Intervention

Patients undergo clinical observation after craniotomy.

Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Stereotactic Radiosurgery for: