Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Launched by NRG ONCOLOGY · Jul 8, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new type of radiation therapy called fractionated stereotactic radiosurgery (FSRS) to see if it works better than the usual radiation therapy (stereotactic radiosurgery or SRS) for patients with cancer that has spread to the brain. FSRS gives a high dose of radiation over three treatments, while SRS delivers a single large dose. The goal is to find out if FSRS can be more effective in shrinking brain tumors caused by different types of cancer, including breast cancer, melanoma, lung cancer, and others.
To participate in this trial, patients must be at least 18 years old and have certain types of solid tumors that have spread to the brain, with specific characteristics detected on recent MRI scans. They should not have had any prior radiation treatment to the brain and must meet other health criteria. If eligible, participants can expect to receive either the new FSRS treatment or the standard SRS treatment, along with regular follow-up care to monitor their progress. This study aims to improve treatment options for patients facing this challenging condition.
Gender
ALL
Eligibility criteria
- 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
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Saint Louis, Missouri, United States
Maywood, Illinois, United States
Newark, New Jersey, United States
Toms River, New Jersey, United States
Oklahoma City, Oklahoma, United States
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New York, New York, United States
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Ann Arbor, Michigan, United States
Delaware, Ohio, United States
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Fort Collins, Colorado, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Gresham, Oregon, United States
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Palo Alto, California, United States
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Delaware, Ohio, United States
Lancaster, California, United States
Saint Peters, Missouri, United States
Pittsburgh, Pennsylvania, United States
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Chai Wan, , Hong Kong
Loveland, Colorado, United States
Sugar Land, Texas, United States
West Chester, Ohio, United States
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Ontario, California, United States
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Chambersburg, Pennsylvania, United States
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Deerfield Beach, Florida, United States
Glen Burnie, Maryland, United States
Chicago, Illinois, United States
Sanford, Maine, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Beavercreek, Ohio, United States
Colorado Springs, Colorado, United States
Corona, California, United States
Plantation, Florida, United States
Bellevue, Nebraska, United States
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Tampa, Florida, United States
Farmington, Missouri, United States
Santa Rosa, California, United States
Upland, California, United States
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Aventura, Florida, United States
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Danville, Illinois, United States
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Crown Point, Indiana, United States
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Olathe, Kansas, United States
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Portland, Maine, United States
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Patients applied
Trial Officials
Rupesh R Kotecha
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported