Study Comparing Longer Radiation Therapy to Usual Radiation Therapy for Cancer Spread to the Brain
Sponsor: NRG Oncology
ClinicalTrials ID:NCT06500455
This clinical trial is testing whether a longer course of radiation therapy is more effective than the usual single-dose radiation therapy for patients whose cancer has spread to the brain. The study aims to see if the longer treatment can better control the cancer.
Patient Parameters
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Program Overview
This study is exploring two different types of radiation therapy for patients with cancer that has spread to the brain. The usual treatment, called stereotactic radiosurgery (SRS), involves a single high dose of radiation aimed precisely at the tumor. The new approach, fractionated stereotactic radiosurgery (FSRS), delivers the radiation over three sessions. The goal is to find out if FSRS is more effective than SRS in controlling brain tumors.
Description
The main goal of this study is to see if the time it takes for the cancer to grow back in the brain is longer with FSRS compared to SRS. Researchers will also look at how long patients live without the cancer getting worse in the brain, overall survival rates, and any differences in how the cancer spreads in the brain. They will compare side effects and the need for additional treatments between the two groups.
Participants will be randomly assigned to one of two groups. One group will receive the usual SRS treatment, which involves a single session of radiation lasting 30-90 minutes. The other group will receive FSRS, which involves three sessions of radiation, each lasting 30-90 minutes. Both groups will have CT and MRI scans as part of the study.
After completing the treatment, participants will have follow-up visits every 3 months for the first year, every 4 months in the second year, and every 6 months for the next three years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with one of the following cancers within the last 5 years: non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma, or gastrointestinal cancer.
- Have 1 to 8 brain tumors that have not been surgically removed, detected on an MRI within 21 days before joining the study.
- At least one tumor must be between 1.0 cm and 3.0 cm in size and located outside the brainstem and at least 5 mm away from the optic nerves.
- Have a specific prognostic score of 1.5 or higher.
- No more than 2 tumors planned for surgical removal.
- No signs of leptomeningeal disease (cancer spread to the lining of the brain and spinal cord).
- Age 18 or older.
- Have a Karnofsky performance status of 60 or higher, meaning able to care for oneself with some assistance.
- Negative pregnancy test for those of childbearing potential.
- No previous radiation treatment to the brain.
- Have a New York Heart Association Functional Classification of II or better, indicating mild symptoms of heart disease.
- No active infections requiring IV antibiotics.
- No severe liver problems causing jaundice or blood clotting issues.
- No severe lung disease preventing participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| City of Hope Corona | 92882 | Corona | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC San Diego Health System - Encinitas | 92024 | Encinitas | California |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
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