Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
3 other identifiers
interventional
480
1 country
391
Brief Summary
This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2020
Longer than P75 for phase_3
391 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 5, 2026
May 1, 2026
7.7 years
December 30, 2019
May 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
From date of randomization to date of death due to any cause, assessed up to 3 years
Secondary Outcomes (2)
Progression free survival
From date of randomization to date of first documentation of progression or death due to any cause, assessed up to 5 years
Incidence of adverse events
Up to 5 years
Other Outcomes (1)
Change in health-related quality of life
Up to 5 years
Study Arms (2)
Arm A (atezolizumab, SBRT)
EXPERIMENTALPatients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Arm B (SBRT)
ACTIVE COMPARATORBeginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Interventions
Undergo PET/CT
Ancillary studies
Given IV
Undergo blood sample collection
Undergo CT or PET/CT
Undergo FDG PET/CT
Undergo SBRT
Eligibility Criteria
You may qualify if:
- Disease must have one or more of the following high-risk features:
- Tumor diameter \>= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT
- Tumor standard uptake value (SUV) max \>= 6.2 as assessed by FDG PET/CT
- Moderately differentiated, poorly differentiated, or undifferentiated histology
- Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
- Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
- Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter \> 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as "non-suspicious" (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record
- Patient must have undergone history and physical examination within 28 days prior to randomization
- Patient must be medically or surgically inoperable as documented by the evaluating thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented
- Patient must not have received any prior treatment for the current NSCLC diagnosis
- Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
- Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
- Patient must be \>= 18 years old
- Patient must have Zubrod performance status of 0-2
- Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (391)
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Tibor Rubin VA Medical Center
Long Beach, California, 90822, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Presbyterian Intercommunity Hospital
Whittier, California, 90602, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Kaiser Permanente-Franklin
Denver, Colorado, 80205, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital-Hamden Care Center
Hamden, Connecticut, 06518, United States
Yale University
New Haven, Connecticut, 06520, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
GenesisCare USA - Aventura FP
Aventura, Florida, 33180, United States
GenesisCare USA - Aventura
Aventura, Florida, 33180, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
GenesisCare USA - Plantation
Plantation, Florida, 33324, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, 34236, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, 34243, United States
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, 30901, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Community Cancer Center South
Indianapolis, Indiana, 46227, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center - Houma
Houma, Louisiana, 70360, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
UM Saint Joseph Medical Center
Towson, Maryland, 21204, United States
Beverly Hospital
Beverly, Massachusetts, 01915, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester, Massachusetts, 01890, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334, United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Michigan Healthcare Professionals Macomb
Macomb, Michigan, 48044, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Mount Sinai Chelsea
New York, New York, 10011, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Good Samaritan University Hospital
West Islip, New York, 11795, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
UNC Health Cancer Care Cary
Cary, North Carolina, 27518, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
UNC Health Cancer Care Garner
Garner, North Carolina, 27529, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284, United States
Novant Health Cancer Institute - Matthews
Matthews, North Carolina, 28105, United States
CarolinaEast Medical Center
New Bern, North Carolina, 28561, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
UNC Health Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
UNC Health Cancer Care Wakefield
Raleigh, North Carolina, 27614, United States
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, 28462, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MD Anderson League City
League City, Texas, 77573, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Ballad Health Cancer Care - Norton
Norton, Virginia, 24273, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
William S Middleton VA Medical Center
Madison, Wisconsin, 53705, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan E Daly
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 2, 2020
Study Start
August 13, 2020
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.