NCT06500455

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

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (estimated)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Metastatic Digestive System Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Renal Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT
RADIATION	Fractionated Stereotactic Radiation Therapy	Undergo FSRS
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
RADIATION	Stereotactic Radiosurgery	Undergo SRS

Timeline

• Start date: 2024-12-12
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2024-07-15
• Last updated: 2026-04-03

Locations

263 sites across 4 countries: United States, Canada, Hong Kong, Ireland