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Search / Trial NCT06500455

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.

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

Duarte, California, United States

New York, New York, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

Delaware, Ohio, United States

Chicago, Illinois, United States

Houston, Texas, United States

Fort Collins, Colorado, United States

Atlanta, Georgia, United States

Austell, Georgia, United States

Gresham, Oregon, United States

Tualatin, Oregon, United States

Renton, Washington, United States

Urbana, Illinois, United States

Effingham, Illinois, United States

Springfield, Illinois, United States

Tampa, Florida, United States

Philadelphia, Pennsylvania, United States

Salt Lake City, Utah, United States

Tucson, Arizona, United States

Orange, California, United States

Palo Alto, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Omaha, Nebraska, United States

Bronx, New York, United States

New York, New York, United States

Syracuse, New York, United States

Fargo, North Dakota, United States

Columbus, Ohio, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Burlington, Vermont, United States

Hartford, Connecticut, United States

New Britain, Connecticut, United States

Lexington, Kentucky, United States

Bronx, New York, United States

Columbus, Ohio, United States

Kettering, Ohio, United States

Honolulu, Hawaii, United States

Elmhurst, Illinois, United States

Livingston, New Jersey, United States

Louisville, Kentucky, United States

Bethlehem, Pennsylvania, United States

Miami, Florida, United States

Stony Brook, New York, United States

Sioux Falls, South Dakota, United States

Houston, Texas, United States

Richmond, Virginia, United States

Miami, Florida, United States

Bronx, New York, United States

Decatur, Illinois, United States

Marietta, Georgia, United States

Los Angeles, California, United States

Walnut Creek, California, United States

Kansas City, Kansas, United States

Portland, Maine, United States

Springfield, Missouri, United States

Reno, Nevada, United States

Cincinnati, Ohio, United States

Mentor, Ohio, United States

Youngstown, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

West Reading, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Burlington, Vermont, United States

Naperville, Illinois, United States

Columbus, Ohio, United States

York, Pennsylvania, United States

Antigo, Wisconsin, United States

Wausau, Wisconsin, United States

Livonia, Michigan, United States

Albuquerque, New Mexico, United States

Tucson, Arizona, United States

Boca Raton, Florida, United States

Appleton, Wisconsin, United States

La Jolla, California, United States

Warrenville, Illinois, United States

San Diego, California, United States

Colorado Springs, Colorado, United States

Scarborough, Maine, United States

Wisconsin Rapids, Wisconsin, United States

Houston, Texas, United States

South Pasadena, California, United States

York, Pennsylvania, United States

Goshen, Indiana, United States

Owensboro, Kentucky, United States

Saint Louis, Missouri, United States

Anaheim, California, United States

Bellflower, California, United States

Overland Park, Kansas, United States

Bel Air, Maryland, United States

Fargo, North Dakota, United States

Vancouver, Washington, United States

Springfield, Illinois, United States

Delaware, Ohio, United States

Lancaster, California, United States

Saint Peters, Missouri, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Chai Wan, , Hong Kong

Loveland, Colorado, United States

Sugar Land, Texas, United States

West Chester, Ohio, United States

Commack, New York, United States

Centralia, Illinois, United States

Decatur, Illinois, United States

Effingham, Illinois, United States

Mattoon, Illinois, United States

New Lenox, Illinois, United States

O'fallon, Illinois, United States

Louisville, Kentucky, United States

Brighton, Michigan, United States

Ypsilanti, Michigan, United States

Conroe, Texas, United States

Houston, Texas, United States

League City, Texas, United States

Montvale, New Jersey, United States

Harrison, New York, United States

Uniondale, New York, United States

Middletown, New Jersey, United States

Ames, Iowa, United States

Basking Ridge, New Jersey, United States

Westminster, Maryland, United States

Creve Coeur, Missouri, United States

Saint Louis, Missouri, United States

New Brunswick, New Jersey, United States

Sewell, New Jersey, United States

Ontario, California, United States

Columbia, Maryland, United States

Chambersburg, Pennsylvania, United States

Orland Park, Illinois, United States

Coral Gables, Florida, United States

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

Omaha, Nebraska, United States

Tampa, Florida, United States

Farmington, Missouri, United States

Santa Rosa, California, United States

Upland, California, United States

Fort Collins, Colorado, United States

Greeley, Colorado, United States

Tampa, Florida, United States

Aventura, Florida, United States

Irvine, California, United States

Philadelphia, Pennsylvania, United States

Vancouver, Washington, United States

Napa, California, United States

Brooklyn, New York, United States

Torrance, California, United States

Springfield, Illinois, United States

Aurora, Colorado, United States

Wesley Chapel, Florida, United States

Shiloh, Illinois, United States

Encinitas, California, United States

Allentown, Pennsylvania, United States

Ann Arbor, Michigan, United States

Danville, Illinois, United States

Quakertown, Pennsylvania, United States

Ames, Iowa, United States

Rhinelander, Wisconsin, United States

Stevens Point, Wisconsin, United States

O'fallon, Illinois, United States

Madison, Wisconsin, United States

Irvine, California, United States

Saginaw, Michigan, United States

Tawas City, Michigan, United States

Crown Point, Indiana, United States

Madison, Wisconsin, United States

Olathe, Kansas, United States

Corona, California, United States

Portland, Maine, United States

Scarborough, Maine, United States

Patients applied

0 patients applied

Trial Officials

Rupesh R Kotecha

Principal Investigator

NRG Oncology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported