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Clinical Trials in Ireland / NCT06500455
Active, not recruiting Phase 3

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

NCT06500455 · tracked via the Priya Life Science Ireland tracker
Sponsor
NRG Oncology
Phase
Phase 3
Started
2024-12-12
Last updated
2026-09-14

Condition(s) studied

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Digestive System CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the BrainMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Renal Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8

Investigational drug(s) / intervention(s)

Computed TomographyFractionated Stereotactic Radiation TherapyMagnetic Resonance ImagingStereotactic Radiosurgery

Computed Tomography: Undergo CT

Fractionated Stereotactic Radiation Therapy: Undergo FSRS

Magnetic Resonance Imaging: Undergo MRI

Stereotactic Radiosurgery: Undergo SRS

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (270)

FacilityCityRegionStatus
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Kaiser Permanente-Anaheim Anaheim California
Kaiser Permanente-Bellflower Bellflower California
City of Hope Corona Corona California
City of Hope Comprehensive Cancer Center Duarte California
UC San Diego Health System - Encinitas Encinitas California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California
City of Hope at Irvine Lennar Irvine California
UC San Diego Moores Cancer Center La Jolla California
City of Hope Antelope Valley Lancaster California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Providence Queen of The Valley Napa California
Kaiser Permanente-Ontario Ontario California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
Stanford Cancer Institute Palo Alto Palo Alto California
UC San Diego Medical Center - Hillcrest San Diego California
Providence Medical Foundation - Santa Rosa Santa Rosa California
City of Hope South Pasadena South Pasadena California
City of Hope South Bay Torrance California
City of Hope Upland Upland California
John Muir Medical Center-Walnut Creek Walnut Creek California
UCHealth University of Colorado Hospital Aurora Colorado
UCHealth Memorial Hospital Central Colorado Springs Colorado
Memorial Hospital North Colorado Springs Colorado
Poudre Valley Hospital Fort Collins Colorado
Cancer Care and Hematology-Fort Collins Fort Collins Colorado
UCHealth Greeley Hospital Greeley Colorado
Medical Center of the Rockies Loveland Colorado
Hartford Hospital Hartford Connecticut
The Hospital of Central Connecticut New Britain Connecticut
UM Sylvester Comprehensive Cancer Center at Aventura Aventura Florida
Boca Raton Regional Hospital Boca Raton Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
UM Sylvester Comprehensive Cancer Center at Doral Doral Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida

+ 230 more sites — see the full list on the official registry below.

More NRG Oncology trials in Ireland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06500455 on ClinicalTrials.gov ↗ ← All trials in Ireland