Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients with Cancer That Has Spread to the Brain

Active:	Yes
Cancer Type:	Breast Cancer Lung Cancer Melanoma	NCT ID:	NCT06500455
Trial Phases:	Phase III	Protocol IDs:	NRG-BN013 (primary) NRG-BN013 NCI-2024-04812
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT06500455

Summary

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Objectives

PRIMARY OBJECTIVE:
I. To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases.

SECONDARY OBJECTIVES:
I. To compare time to intracranial progression-free survival between FSRS and SRS.
II. To compare overall survival between FSRS and SRS.
III. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging.
IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (local versus [vs.] distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS.
V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS.
VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients who receive FSRS and those who receive SRS.
VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study.

ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year then every 6 months for 3 years.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.