Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
SAMURAI
Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
3 other identifiers
interventional
240
4 countries
318
Brief Summary
This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
Longer than P75 for phase_2
318 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
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2028
May 4, 2026
April 1, 2026
5.4 years
April 7, 2022
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Nephrectomy and radiographic progression-free survival (nrPFS)
Nephrectomy and radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, nephrectomy, death, or last negative evaluation (censored). nrPFS rates are estimated using the Kaplan-Meier method. Progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST).
From randomization to last follow-up, up to 8 years
Secondary Outcomes (9)
Percentage of participants with complete or partial response
From randomization to disease progression
Percentage of participants with complete or partial response in the primary renal mass
From randomization to disease progression
Radiographic progression-free survival (rPFS)
From randomization to last follow-up, up to 8 years
Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2)
From randomization to last follow-up, up to 8 years
Overall survival
From randomization to last follow-up, up to 8 years
- +4 more secondary outcomes
Other Outcomes (5)
nrPFS and overall survival
From randomization to last follow-up, up to 8 years
Prognostic and predictive biomarkers
From randomization to last follow-up, up to 8 years
Abscopal effect of SABR with systemic therapy
From randomization to disease progression
- +2 more other outcomes
Study Arms (2)
Arm I (standard of care immunotherapy)
ACTIVE COMPARATORPatients receive one of the following immunotherapy regimens per physician discretion: nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib PO BID; avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO QD; OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Arm II (SABR, standard of care immunotherapy)
EXPERIMENTALPatients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Interventions
Given PO
Undergo MRI
Given IV
Given IV
42 Gy in 3 fractions
Given IV
Given PO
Undergo collection of blood
Undergo bone scan
Given PO
Undergo CT
Given IV
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration
- Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:
- History/physical examination within 45 days prior to registration
- CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration
- Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor
- Patient not recommended for or refused immediate cytoreductive nephrectomy
- Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen
- Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging
- Age \>= 18
- Karnofsky performance status \>= 60 within 45 days prior to registration
- Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)
- Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration)
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration)
- +10 more criteria
You may not qualify if:
- Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment
- Patients with untreated or unstable brain metastases or cranial epidural disease
- Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
- Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
- Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated \> 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration)
- Severe, active comorbidity defined as follows:
- Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies
- Active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed)
- Uncontrolled hypertension (systolic blood pressure \[BP\] \>= 190 mmHg or diastolic BP \> 110 mmHg)
- Major surgery requiring hospital admission =\< 28 days prior to registration
- Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration
- Any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-ST elevation myocardial infarction \[NSTEMI\], cerebrovascular accident \[CVA\], etc) events within 180 days prior to registration
- Active New York (NY) Heart Association class 3-4 heart failure symptoms
- Moderate or severe hepatic impairment (Child-Pugh B or C)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (318)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Memorial Medical Center
Modesto, California, 95355, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Mills Health Center
San Mateo, California, 94401, United States
Ridley-Tree Cancer Center
Santa Barbara, California, 93105, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth - Cherry Creek
Denver, Colorado, 80206, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado, 80124, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Beebe Medical Center
Lewes, Delaware, 19958, 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
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, 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
Alton Memorial Hospital
Alton, Illinois, 62002, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Memorial Hospital East
Shiloh, Illinois, 62269, 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
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, 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 - Metairie
Metairie, Louisiana, 70002, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Touro Infirmary
New Orleans, Louisiana, 70115, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Beverly Hospital
Beverly, Massachusetts, 01915, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960, 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
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336, 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
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, 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
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Cooper CyberKnife Center
Mount Laurel, New Jersey, 08054, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102, United States
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, 11740, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, 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
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Duke Cancer Center Cary
Cary, North Carolina, 27518, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210, United States
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262, United States
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, 28277, United States
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054, United States
Hayworth Cancer Center
High Point, North Carolina, 27262, United States
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609, United States
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, 28659, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, 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
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, 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
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, 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
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Marshfield Medical Center - Neillsville
Neillsville, Wisconsin, 54456, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, 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
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, 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
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Beacon Hospital
Dublin, Co Dublin, 18, Ireland
Saint Lukes Hospital
Dublin, Co Dublin, 6, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William A Hall
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 14, 2022
Study Start
February 1, 2023
Primary Completion (Estimated)
June 15, 2028
Study Completion (Estimated)
June 15, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04
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.