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Search / Trial NCT06745024

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 23, 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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported