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ACTIVE NOT RECRUITING

NCT06500455

PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2024-12-12

Completion Date

2033-06-30

Last Updated

2026-09-14

Healthy Volunteers

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

PROCEDURE

Computed Tomography

Undergo CT

RADIATION

Fractionated Stereotactic Radiation Therapy

Undergo FSRS

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

RADIATION

Stereotactic Radiosurgery

Undergo SRS

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: * Non-small cell lung cancer * Melanoma * Breast cancer * Renal cell carcinoma * Gastrointestinal cancer * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, etc.) is required * Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration * At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm * All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension * Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator * Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5 * No more than 2 lesions planned for resection if clinically indicated * No known leptomeningeal disease (LMD) * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion * Age ≥ 18 years * Karnofsky performance status (KPS) ≥ 60 * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\]) * New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) * No active infection currently requiring intravenous (IV) antibiotic management * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

Locations (270)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

City of Hope Corona

Corona, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Health System - Encinitas

Encinitas, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Providence Queen of The Valley

Napa, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope South Bay

Torrance, California, United States

City of Hope Upland

Upland, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza