Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases
Launched by NRG ONCOLOGY · Dec 17, 2024
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether adding radiation therapy to the usual care can help prevent problems related to high-risk bone metastases in cancer patients who do not have symptoms. High-risk bone metastases are cancer spreads in the bones that are larger than 2 centimeters or located in critical areas like the hips or spine. The trial aims to find out if using radiation therapy, which uses high-energy x-rays to target cancer cells, can reduce complications like fractures or severe pain compared to standard treatments, which might involve monitoring or medications to strengthen bones.
To be eligible for this trial, participants must be adults aged 18 or older with a specific type of cancer that has spread to more than five areas of the body, excluding the brain. They should have asymptomatic bone metastases that meet certain criteria, such as size or location. Participants will be treated with radiation either in one session or over several days, alongside their regular cancer care. This trial is not yet recruiting participants, but it hopes to help determine the best way to manage and prevent complications from high-risk bone metastases in cancer patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • • Patients with polymetastatic cancer defined as more than 5 sites of radiographically-evident systemic metastatic disease (excluding intracranial disease)
- * "High-risk" asymptomatic bone metastasis (Brief Pain Inventory \[BPI\] score of \< 5 on the "maximum" pain item) defined as fulfilling at least one of the following four high-risk criteria:
- • Bulky site of disease in bone ( ≥ 2 cm);
- • Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints;
- • Disease in long bones occupying up to 2/3 of the cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges); and/or
- • Disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterolateral element (pedicles and/or facet joints) involvement
- • NOTE: Sternum, rib, and scapula are defined as flat bones so lesions in these locations would only be included if bulky
- • Patients with any solid tumor type (excluding multiple myeloma)
- • Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body positron emission tomography (PET)/CT, with radiology report available
- • Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment
- • Age ≥ 18
- • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status (KPS) ≥ 60
- • No previous radiotherapy to the intended enrolled sites of disease
- • No epidural spinal cord compression (ESCC) ≥ grade 1c (defined as deformation of the thecal sac with spinal cord abutment) at the enrolled bone metastasis(es)
- • No prior fracture at the enrolled bone metastasis(es)
- Exclusion Criteria:
- • -
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
Edina, Minnesota, United States
Waconia, Minnesota, United States
Peoria, Illinois, United States
Des Moines, Iowa, United States
Great Falls, Montana, United States
Baltimore, Maryland, United States
Saint Paul, Minnesota, United States
Cincinnati, Ohio, United States
Lewes, Delaware, United States
Coon Rapids, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Effingham, Illinois, United States
Greenville, Ohio, United States
Longmont, Colorado, United States
Springfield, Illinois, United States
Cincinnati, Ohio, United States
Roseville, California, United States
Minneapolis, Minnesota, United States
Aurora, Colorado, United States
Modesto, California, United States
Orange, California, United States
Baltimore, Maryland, United States
Duluth, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Louis, Missouri, United States
Kearney, Nebraska, United States
Winston Salem, North Carolina, United States
Hershey, Pennsylvania, United States
Newark, Delaware, United States
Louisville, Kentucky, United States
Bronx, New York, United States
Kettering, Ohio, United States
Morgantown, West Virginia, United States
Cape Girardeau, Missouri, United States
Martinez, California, United States
Denver, Colorado, United States
Pueblo, Colorado, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Sacramento, California, United States
Bronx, New York, United States
Green Bay, Wisconsin, United States
Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Brainerd, Minnesota, United States
Duluth, Minnesota, United States
Duluth, Minnesota, United States
Omaha, Nebraska, United States
Peru, Illinois, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Stillwater, Minnesota, United States
Findlay, Ohio, United States
Princeton, West Virginia, United States
Rohnert Park, California, United States
Sacramento, California, United States
Richmond, California, United States
Sacramento, California, United States
San Leandro, California, United States
Santa Barbara, California, United States
Santa Clara, California, United States
Stockton, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Galesburg, Illinois, United States
Richmond, Indiana, United States
Easton, Maryland, United States
Woodbury, Minnesota, United States
Billings, Montana, United States
Cincinnati, Ohio, United States
Youngstown, Ohio, United States
Portland, Oregon, United States
Ephrata, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Richmond, Virginia, United States
Green Bay, Wisconsin, United States
Oconomowoc, Wisconsin, United States
Kettering, Ohio, United States
Berkeley, California, United States
Mountain View, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
York, Pennsylvania, United States
Castro Valley, California, United States
Honolulu, Hawaii, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Boise, Idaho, United States
Louisville, Kentucky, United States
Fargo, North Dakota, United States
Warrenville, Illinois, United States
Burlingame, California, United States
Vallejo, California, United States
Post Falls, Idaho, United States
Bloomington, Illinois, United States
Geneva, Illinois, United States
Pekin, Illinois, United States
Erie, Pennsylvania, United States
Parkersburg, West Virginia, United States
Auburn, California, United States
Cameron Park, California, United States
Carmichael, California, United States
Roseville, California, United States
Peoria, Illinois, United States
York, Pennsylvania, United States
Bloomington, Illinois, United States
Wheeling, West Virginia, United States
Santa Rosa, California, United States
Gettysburg, Pennsylvania, United States
Fairbanks, Alaska, United States
Vacaville, California, United States
Goshen, Indiana, United States
Omaha, Nebraska, United States
Bridgeport, West Virginia, United States
Antioch, California, United States
Modesto, California, United States
Oakland, California, United States
Rancho Cordova, California, United States
South San Francisco, California, United States
Sunnyvale, California, United States
Bel Air, Maryland, United States
New Richmond, Wisconsin, United States
Springfield, Illinois, United States
Monroeville, Pennsylvania, United States
Greensburg, Pennsylvania, United States
Johnstown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Great Falls, Montana, United States
Auburn, California, United States
Santa Cruz, California, United States
Newark, Delaware, United States
Newark, Delaware, United States
Rehoboth Beach, Delaware, United States
Wilmington, Delaware, United States
Caldwell, Idaho, United States
Coeur D'alene, Idaho, United States
Meridian, Idaho, United States
Clive, Iowa, United States
West Des Moines, Iowa, United States
West Chester, Ohio, United States
Colorado Springs, Colorado, United States
Thornton, Colorado, United States
Creston, Iowa, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Boulder, Colorado, United States
Littleton, Colorado, United States
Carbondale, Illinois, United States
Carterville, Illinois, United States
Centralia, Illinois, United States
Decatur, Illinois, United States
O'fallon, Illinois, United States
Maple Grove, Minnesota, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Findlay, Ohio, United States
Findlay, Ohio, United States
Franklin, Ohio, United States
Greenville, Ohio, United States
Sturgeon Bay, Wisconsin, United States
Ames, Iowa, United States
Bakersfield, California, United States
Dublin, California, United States
Fresno, California, United States
Sacramento, California, United States
San Rafael, California, United States
Westminster, Maryland, United States
Monticello, Minnesota, United States
Lebanon, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Fremont, California, United States
Mukwonago, Wisconsin, United States
Waukesha, Wisconsin, United States
Louisville, Kentucky, United States
Ashland, Wisconsin, United States
Columbia, Maryland, United States
Chambersburg, Pennsylvania, United States
Midlothian, Virginia, United States
Glen Burnie, Maryland, United States
Phoenix, Arizona, United States
Elk Grove, California, United States
Rocklin, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Woodland, California, United States
Bath, Maine, United States
Sanford, Maine, United States
Baltimore, Maryland, United States
Dekalb, Illinois, United States
Beavercreek, Ohio, United States
Arroyo Grande, California, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Ashland, Wisconsin, United States
Stockton, California, United States
Mechanicsville, Virginia, United States
Farrell, Pennsylvania, United States
Detroit Lakes, Minnesota, United States
Fosston, Minnesota, United States
Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Mechanicsburg, Pennsylvania, United States
Chadds Ford, Pennsylvania, United States
Madison, Wisconsin, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Redwood City, California, United States
San Mateo, California, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Burnsville, Minnesota, United States
Richmond, Virginia, United States
Bozeman, Montana, United States
Clemmons, North Carolina, United States
Statesville, North Carolina, United States
Indiana, Pennsylvania, United States
Wilkesboro, North Carolina, United States
Louisville, Kentucky, United States
Missoula, Montana, United States
Hayward, Wisconsin, United States
Spooner, Wisconsin, United States
Superior, Wisconsin, United States
Springfield, Illinois, United States
Lexington, Kentucky, United States
Pekin, Illinois, United States
Sheboygan, Wisconsin, United States
Kalispell, Montana, United States
Lebanon, New Hampshire, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Meadowbrook, Pennsylvania, United States
Orland Park, Illinois, United States
Ames, Iowa, United States
Sunset Hills, Missouri, United States
O'fallon, Illinois, United States
Carmichael, California, United States
Silverdale, Washington, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Walnut Creek, California, United States
Irvine, California, United States
Millville, Delaware, United States
Havre, Montana, United States
Westminster, Colorado, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Waukee, Iowa, United States
South Portland, Maine, United States
Portland, Maine, United States
Damariscotta, Maine, United States
Oak Brook, Illinois, United States
Scarborough, Maine, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported