Radiosurgery vs Whole Brain Radiation for Brain Metastasis

Palo Alto (17 mi)

Overseen byJing Li

Age: 18+

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

Trial Summary

What is the purpose of this trial?This trial compares two radiation treatments for brain tumors from non-melanoma cancers. One treatment is a focused, high-dose method, while the other treats the entire brain over several sessions. The goal is to determine which method controls tumors better and has fewer side effects on thinking and memory. The focused, high-dose method has been increasingly used over the past years as an effective treatment for brain metastases, often replacing the whole brain treatment due to its ability to improve outcomes and reduce side effects.

Eligibility Criteria

This trial is for adults with non-melanoma cancer that has spread to the brain, with 3-15 detectable lesions on MRI. Participants must have proof of malignant cancer and be able to undergo all treatments proposed. They should not have had prior brain surgery or whole-brain radiation, no melanoma or certain other cancers, and women of childbearing age must not be pregnant.

Inclusion Criteria

My cancer is confirmed to be spreading, based on a tissue sample.

I am 18 years old or older.

All my cancer spots can be treated with focused radiation because they are small enough.

My liver, kidney, and blood tests are within normal ranges.

Exclusion Criteria

I have not had surgery to remove cancer from my brain.

I do not have cancer spread to the lining of my brain and spinal cord.

I do not have melanoma, small cell carcinoma, lymphoma/leukemia, or germ cell cancer.

Treatment Details

The study compares stereotactic radiosurgery (SRS), which targets tumors directly in a single high dose, against whole-brain radiotherapy (WBRT) that treats the entire brain over multiple sessions. The goal is to determine which method is more effective for treating brain metastases from non-melanoma cancers and causes fewer cognitive side effects.

2Treatment groups

Experimental Treatment

Group I: Arm II (WBRT)Experimental Treatment3 Interventions

Patients undergo WBRT 5 days per week (7 days per week for inpatients) for 2 weeks.

Group II: Arm I (SRS)Experimental Treatment3 Interventions

Patients undergo SRS on day 1.

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: