Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases
Purpose
This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
Conditions
- Metastatic Malignant Neoplasm in the Bone
- Metastatic Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (standard of care) |
Patients continue to receive SOC systemic anti-cancer therapy or observation and bone modifying agents as determined by the treating physician. Additionally, patients optional blood sample collection on study. |
|
|
Experimental Arm II (RT, SOC) |
Patients continue SOC as in Arm I. Patients also undergo conventional RT or SBRT QD for up to 5 days (5 fractions) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and optional blood sample collection on study. |
|
Recruiting Locations
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Fairbanks, Alaska 99701
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Phoenix, Arizona 85004
Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Antioch, California 94531
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Sutter Auburn Faith Hospital
Auburn, California 95602
Auburn, California 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Auburn, California 95603
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California 93301
Bakersfield, California 93301
Contact:
Site Public Contact
661-323-4673
Site Public Contact
661-323-4673
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Berkeley, California 94704
Mills-Peninsula Medical Center
Burlingame, California 94010
Burlingame, California 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California 95682
Cameron Park, California 95682
Mercy Cancer Center - Carmichael
Carmichael, California 95608
Carmichael, California 95608
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
Eden Hospital Medical Center
Castro Valley, California 94546
Castro Valley, California 94546
Kaiser Permanente Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Elk Grove, California 95758
Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Fremont, California 94538
Fresno Cancer Center
Fresno, California 93720
Fresno, California 93720
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
Irvine, California 92612
Contra Costa Regional Medical Center
Martinez, California 94553-3156
Martinez, California 94553-3156
Contact:
Site Public Contact
925-957-5400
Site Public Contact
925-957-5400
Memorial Medical Center
Modesto, California 95355
Modesto, California 95355
Kaiser Permanente-Modesto
Modesto, California 95356
Modesto, California 95356
Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Mountain View, California 94040
Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Oakland, California 94611
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Orange, California 92868
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Palo Alto, California 94301
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Rancho Cordova, California 95670
Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Richmond
Richmond, California 94801
Richmond, California 94801
Mercy Cancer Center - Rocklin
Rocklin, California 95765
Rocklin, California 95765
Rohnert Park Cancer Center
Rohnert Park, California 94928
Rohnert Park, California 94928
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Roseville, California 95661
Sutter Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Sacramento, California 95814
Mercy Cancer Center - Sacramento
Sacramento, California 95816
Sacramento, California 95816
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Sacramento, California 95823
South Sacramento Cancer Center
Sacramento, California 95823
Sacramento, California 95823
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente San Leandro
San Leandro, California 94577
San Leandro, California 94577
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Mills Health Center
San Mateo, California 94401
San Mateo, California 94401
Kaiser San Rafael-Gallinas
San Rafael, California 94903
San Rafael, California 94903
Ridley-Tree Cancer Center
Santa Barbara, California 93105
Santa Barbara, California 93105
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Santa Clara, California 95051
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Santa Cruz, California 95065
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
Santa Maria, California 93444
Sutter Pacific Medical Foundation
Santa Rosa, California 95403
Santa Rosa, California 95403
Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
South San Francisco, California 94080
Saint Joseph's Medical Center
Stockton, California 95204
Stockton, California 95204
Contact:
Site Public Contact
209-461-5257
Site Public Contact
209-461-5257
Kaiser Permanente-Stockton
Stockton, California 95210
Stockton, California 95210
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Sunnyvale, California 94086
Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Vacaville, California 95688
Kaiser Permanente-Vallejo
Vallejo, California 94589
Vallejo, California 94589
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Vallejo, California 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Walnut Creek, California 94596
BASS Medical Group - Lennon
Walnut Creek, California 94598
Walnut Creek, California 94598
Woodland Memorial Hospital
Woodland, California 95695
Woodland, California 95695
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Aurora, Colorado 80012
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Boulder, Colorado 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Saint Francis Cancer Center
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
Denver, Colorado 80218
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113
Englewood, Colorado 80113
Saint Anthony Hospital
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Littleton, Colorado 80120
Longmont United Hospital
Longmont, Colorado 80501
Longmont, Colorado 80501
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Pueblo, Colorado 81004
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260
Thornton, Colorado 80260
Saint Anthony North Hospital
Westminster, Colorado 80023
Westminster, Colorado 80023
Beebe Medical Center
Lewes, Delaware 19958
Lewes, Delaware 19958
Beebe South Coastal Health Campus
Millville, Delaware 19967
Millville, Delaware 19967
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Newark, Delaware 19718
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
Wilmington, Delaware 19801
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
Honolulu, Hawaii 96819
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
OSF Saint Joseph Medical Center
Bloomington, Illinois 61701
Bloomington, Illinois 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
Oak Brook, Illinois 60523
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
OSF Saint Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield, Illinois 62781
Springfield, Illinois 62781
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Goshen Center for Cancer Care
Goshen, Indiana 46526
Goshen, Indiana 46526
Reid Health
Richmond, Indiana 47374
Richmond, Indiana 47374
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Clive, Iowa 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Greater Regional Medical Center
Creston, Iowa 50801
Creston, Iowa 50801
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
Waukee, Iowa 50263
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Saint Joseph Hospital
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Hospital East
Lexington, Kentucky 40509
Lexington, Kentucky 40509
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Contact:
Site Public Contact
502-629-3465
Site Public Contact
502-629-3465
Norton Audubon Hospital and Medical Campus
Louisville, Kentucky 40217
Louisville, Kentucky 40217
Contact:
Site Public Contact
502-629-3465
Site Public Contact
502-629-3465
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky 40241
Louisville, Kentucky 40241
MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
Bath, Maine 04530
MaineHealth LincolnHealth Hospital
Damariscotta, Maine 04543
Damariscotta, Maine 04543
MaineHealth Maine Medical Center - Portland
Portland, Maine 04102
Portland, Maine 04102
MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600
Site Public Contact
207-459-1600
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
Scarborough, Maine 04074
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
South Portland, Maine 04106
Maryland Proton Treatment Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Baltimore, Maryland 21215
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010
Site Public Contact
443-643-3010
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300
Site Public Contact
443-546-1300
University of Maryland Shore Medical Center at Easton
Easton, Maryland 21601
Easton, Maryland 21601
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100
Site Public Contact
410-553-8100
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland 21157
Westminster, Maryland 21157
Contact:
Site Public Contact
410-871-6400
Site Public Contact
410-871-6400
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Brainerd, Minnesota 56401
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Detroit Lakes, Minnesota 56501
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Miller-Dwan Hospital
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Essentia Health - Fosston
Fosston, Minnesota 56542
Fosston, Minnesota 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Park Rapids, Minnesota 56470
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Great Falls Clinic
Great Falls, Montana 59405
Great Falls, Montana 59405
Hi-Line Sletten Cancer Center
Havre, Montana 59501
Havre, Montana 59501
Logan Health Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Center
Missoula, Montana 59804
Missoula, Montana 59804
CHI Health Good Samaritan
Kearney, Nebraska 68847
Kearney, Nebraska 68847
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Creighton University Medical Center
Omaha, Nebraska 68131
Omaha, Nebraska 68131
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Bronx, New York 10461
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Bronx, New York 10467
Wake Forest University at Clemmons
Clemmons, North Carolina 27012
Clemmons, North Carolina 27012
Contact:
Site Public Contact
888-716-9259
Site Public Contact
888-716-9259
Wake Forest Baptist Health - Hematology Oncology - Statesville
Statesville, North Carolina 28677
Statesville, North Carolina 28677
Contact:
Site Public Contact
704-872-3630
Site Public Contact
704-872-3630
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina 28659
Wilkesboro, North Carolina 28659
Contact:
Site Public Contact
888-716-9253
Site Public Contact
888-716-9253
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Essentia Health - Jamestown Clinic
Jamestown, North Dakota 58401
Jamestown, North Dakota 58401
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Bethesda North Hospital
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Dayton Physician LLC - Englewood
Dayton, Ohio 45415
Dayton, Ohio 45415
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Blanchard Valley Hospital
Findlay, Ohio 45840
Findlay, Ohio 45840
Orion Cancer Care
Findlay, Ohio 45840
Findlay, Ohio 45840
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Franklin, Ohio 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Greenville, Ohio 45331
Wayne Hospital
Greenville, Ohio 45331
Greenville, Ohio 45331
Greater Dayton Cancer Center
Kettering, Ohio 45409
Kettering, Ohio 45409
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Dayton Physicians LLC - Troy
Troy, Ohio 45373
Troy, Ohio 45373
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
West Chester, Ohio 45069
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Youngstown, Ohio 44501
Kaiser Permanente Northwest
Portland, Oregon 97227
Portland, Oregon 97227
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Chadds Ford, Pennsylvania 19317
Chambersburg Hospital
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840
Site Public Contact
717-721-4840
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
Adams Cancer Center
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Hershey, Pennsylvania 17033-0850
IRMC Cancer Center
Indiana, Pennsylvania 15701
Indiana, Pennsylvania 15701
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Johnstown, Pennsylvania 15901
Contact:
Site Public Contact
814-534-4724
Site Public Contact
814-534-4724
Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Lebanon, Pennsylvania 17042
Redeemer Health
Meadowbrook, Pennsylvania 19046
Meadowbrook, Pennsylvania 19046
Contact:
Site Public Contact
215-938-3555
Site Public Contact
215-938-3555
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811
Site Public Contact
412-647-2811
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
WellSpan Health-York Cancer Center
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
WellSpan Health-York Hospital
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
Saint Johnsbury, Vermont 05819
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
Mechanicsville, Virginia 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
Richmond, Virginia 23226
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Richmond, Virginia 23230
Saint Michael Cancer Center
Silverdale, Washington 98383
Silverdale, Washington 98383
United Hospital Center
Bridgeport, West Virginia 26330
Bridgeport, West Virginia 26330
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Camden Clark Medical Center
Parkersburg, West Virginia 26101
Parkersburg, West Virginia 26101
Princeton Community Hospital
Princeton, West Virginia 24740
Princeton, West Virginia 24740
Contact:
Site Public Contact
304-487-7515
Site Public Contact
304-487-7515
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia 26003
Wheeling, West Virginia 26003
Contact:
Site Public Contact
304-243-6442
Site Public Contact
304-243-6442
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
William S Middleton VA Medical Center
Madison, Wisconsin 53705
Madison, Wisconsin 53705
Contact:
Site Public Contact
608-256-1901
Site Public Contact
608-256-1901
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
Milwaukee, Wisconsin 53295
Contact:
Site Public Contact
888-469-6614
Site Public Contact
888-469-6614
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
Spooner, Wisconsin 54801
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
Superior, Wisconsin 54880
Contact:
Site Public Contact
701-364-6272
Site Public Contact
701-364-6272
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
More Details
- NCT ID
- NCT06745024
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether prophylactic radiation therapy (RT) to high-risk asymptomatic bone metastases decreases the occurrence of skeletal-related events (SREs), including pathologic fracture, spinal cord compression, and surgery to bone (not including palliative radiation for pain only), compared to standard of care (SOC). SECONDARY OBJECTIVES: I. To compare overall survival (OS) between study arms. II. To compare occurrence of any SREs (including RT for palliation of pain) among enrolled bone metastasis(es) between study arms. III. To compare occurrence of hospitalizations related to any SREs in enrolled bone metastasis(es) between study arms. IV. To compare pain-related quality of life (QOL) between study arms. V. To characterize adverse events of RT and compare to SOC. EXPLORATORY OBJECTIVES: I. To evaluate overall QOL, functional status, and quality-adjusted life years between study arms. II. To evaluate any hospitalizations (from any cause) between study arms. III. To characterize differences in primary and secondary endpoints between study arms (a) among the represented racial and ethnic groups (e.g. Black, White, Hispanic/Latino, Asian/Pacific Islander, and Native American) and (b) by sex. IV. To evaluate the heterogeneity of radiation treatment effect based on cancer-related factors (histology, criteria indicating high-risk for SRE), treatment-related factors (bone modifying agent use, radiation dose/ technique), and patient demographic factors (age, sex, race/ethnicity, and health-related social needs). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients continue to receive SOC systemic anti-cancer therapy or observation and bone modifying agents as determined by the treating physician. Additionally, patients undergo optional blood sample collection on study. ARM II: Patients continue SOC as in Arm I. Patients also undergo conventional RT or stereotactic body radiation therapy (SBRT) once daily (QD) for up to 5 days (5 fractions) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and optional blood sample collection on study. After completion of study treatment, patients are followed up at 3, 6, 12 and 24 months.