Recruiting
Phase 3

Ultra-Hypofractionated Radiation & Chemotherapy

Sponsor:

NRG Oncology

Code:

NCT07097142

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cisplatin

Computed Tomography

Fluorouracil

Gemcitabine

Study Details

Brief summary:

This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Study ID

NCT07097142

Start date

Oct 7, 2025

Status verified date

Aug, 2026

Completion date

May 31, 2035

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.

  • Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible
  • Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection
  • Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging
  • If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT / MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization
  • No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy
  • No definitive clinical or radiologic evidence of metastatic disease
  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy
  • Age ≥ 18
  • Zubrod performance status of ≤ 2
  • Not pregnant and not nursing

  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  • Platelets ≥ 100,000 cells/mm\^3
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\]) ≥ 8.0 g/dl is acceptable)
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
  • All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization
  • For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization
  • Must not have had prior pelvic radiation
  • New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  • No active infection requiring IV antibiotics
  • Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified

Study Design

Enrollment

486 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (hypofractionated radiation therapy)

Patients receive hypofractionated RT QD, Monday to Friday, for 20 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.

experimental: Arm II (Ultrahypofractionated radiation therapy)

Patients receive ultra-hypofractionated RT QD, no more than twice weekly, for 5 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.

Interventions

Biospecimen Collection

Undergo blood, tissue, and urine sample collection

Cisplatin

Given IV

Computed Tomography

Undergo CT scan

Fluorouracil

Given IV

Gemcitabine

Given IV

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Magnetic Resonance Imaging

Undergo MRI

Mitomycin

Given IV

Positron Emission Tomography

Undergo PET scan

Survey Administration

Ancillary studies

Ultrahypofractionated Radiation Therapy

Undergo ultrahypofractionated radiation therapy.

Primary outcome measure

  • Bladder-intact event-free survival (BI-EFS) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Mercy Hospital Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Site Public Contact

800-378-9373

Principal Investigator:

Jay W. Carlson

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Shera Feinstein

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Aditya Bagrodia

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Shera Feinstein

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Richard K. Valicenti

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Tyler Robin

UCHealth - Cherry Creek

Recruiting

Denver, Colorado, United States, 80206

Contacts

Principal Investigator:

Tyler Robin

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Tyler Robin

UCHealth Lone Tree Health Center

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Principal Investigator:

Tyler Robin

Beebe Medical Center

Recruiting

Lewes, Delaware, United States, 19958

Contacts

Principal Investigator:

Gregory A. Masters

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Christiana Hospital

Recruiting

Newark, Delaware, United States, 19718

Contacts

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Wilmington Hospital

Recruiting

Wilmington, Delaware, United States, 19801

Contacts

Principal Investigator:

Gregory A. Masters

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Alan Libardi Dal Pra

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Alan Libardi Dal Pra

UM Sylvester Comprehensive Cancer Center at Doral

Recruiting

Doral, Florida, United States, 33166

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

Alan Libardi Dal Pra

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Alan Libardi Dal Pra

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Adeel Kaiser

UM Sylvester Comprehensive Cancer Center at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Alan Libardi Dal Pra

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

Alan Libardi Dal Pra

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Alan Libardi Dal Pra

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Natalie A. Ridge

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Natalie A. Ridge

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Natalie A. Ridge

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Natalie A. Ridge

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

OSF Saint Anthony's Health Center

Recruiting

Alton, Illinois, United States, 62002

Contacts

Site Public Contact

618-463-5623

Principal Investigator:

Jay W. Carlson

OSF Saint Joseph Medical Center

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Memorial Hospital of Carbondale

Recruiting

Carbondale, Illinois, United States, 62902

Contacts

Principal Investigator:

Bryan A. Faller

SIH Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Centralia Oncology Clinic

Recruiting

Centralia, Illinois, United States, 62801

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Sean Sachdev

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Dian Wang

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Karine Tawagi

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Principal Investigator:

Jay W. Carlson

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Rush MD Anderson Cancer Center at Rush Oak Park

Recruiting

Oak Park, Illinois, United States, 60304

Contacts

Principal Investigator:

Dian Wang

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Sean Sachdev

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61636

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Cancer Center-West Lakes

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Greater Regional Medical Center

Recruiting

Creston, Iowa, United States, 50801

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center-West Lakes

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

The Iowa Clinic PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-875-9815

Principal Investigator:

Seema Harichand-Herdt

Central Care Cancer Center - Garden City

Recruiting

Garden City, Kansas, United States, 67846

Contacts

Principal Investigator:

Jay W. Carlson

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Jay C. Shiao

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Principal Investigator:

Jay C. Shiao

Mercy Hospital Pittsburg

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Jay C. Shiao

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Jay C. Shiao

Ascension Via Christi Hospitals Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Principal Investigator:

Dennis F. Moore

Louisiana Hematology Oncology Associates LLC

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Principal Investigator:

Scott E. Delacroix

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Principal Investigator:

Scott E. Delacroix

Mary Bird Perkins Cancer Center - Metairie

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Site Public Contact

504-584-6990

Principal Investigator:

Scott E. Delacroix

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Xin Gao

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Irene Tsung

Bronson Battle Creek

Recruiting

Battle Creek, Michigan, United States, 49017

Contacts

Principal Investigator:

Kathleen Y. Butler

University of Michigan - Brighton Center for Specialty Care

Recruiting

Brighton, Michigan, United States, 48116

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Irene Tsung

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Principal Investigator:

Aharon M. Feldman

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Principal Investigator:

Aharon M. Feldman

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Principal Investigator:

Aharon M. Feldman

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Aharon M. Feldman

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Trinity Health Grand Rapids Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Allegiance Health

Recruiting

Jackson, Michigan, United States, 49201

Contacts

Principal Investigator:

Aharon M. Feldman

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo

Recruiting

Kalamazoo, Michigan, United States, 49048

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Trinity Health Muskegon Hospital

Recruiting

Muskegon, Michigan, United States, 49444

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Cancer and Hematology Centers of Western Michigan - Norton Shores

Recruiting

Norton Shores, Michigan, United States, 49444

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Principal Investigator:

Aharon M. Feldman

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Principal Investigator:

Aharon M. Feldman

Henry Ford Wyandotte Hospital

Recruiting

Wyandotte, Michigan, United States, 48192

Contacts

Site Public Contact

nhay@hfhs.org

Principal Investigator:

Aharon M. Feldman

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Principal Investigator:

Kathleen Y. Butler

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Principal Investigator:

Charles Shideman

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Charles Shideman

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

Charles Shideman

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

Charles Shideman

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

Charles Shideman

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

Charles Shideman

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Charles Shideman

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

Charles Shideman

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Principal Investigator:

Charles Shideman

North Memorial Medical Health Center

Recruiting

Robbinsdale, Minnesota, United States, 55422

Contacts

Principal Investigator:

Charles Shideman

Coborn Cancer Center at Saint Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Principal Investigator:

Donald J. Jurgens

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

Charles Shideman

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

Charles Shideman

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Charles Shideman

Saint Francis Regional Medical Center

Recruiting

Shakopee, Minnesota, United States, 55379

Contacts

Principal Investigator:

Charles Shideman

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Principal Investigator:

Charles Shideman

Ridgeview Medical Center

Recruiting

Waconia, Minnesota, United States, 55387

Contacts

Principal Investigator:

Charles Shideman

Rice Memorial Hospital

Recruiting

Willmar, Minnesota, United States, 56201

Contacts

Principal Investigator:

Charles Shideman

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Principal Investigator:

Charles Shideman

Central Care Cancer Center - Bolivar

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Cancer Center - Cape Girardeau

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

MU Health - University Hospital/Ellis Fischel Cancer Center

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Site Public Contact

573-882-7440

Principal Investigator:

Gregory B. Biedermann

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

University of Kansas Cancer Center - Briarcliff

Recruiting

Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671

Principal Investigator:

Jay C. Shiao

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Principal Investigator:

Jay C. Shiao

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Principal Investigator:

Jay C. Shiao

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Clinic-Rolla-Cancer and Hematology

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Site Public Contact

573-458-6379

Principal Investigator:

Jay W. Carlson

Phelps Health Delbert Day Cancer Institute

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Principal Investigator:

Jay W. Carlson

Heartland Regional Medical Center

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Principal Investigator:

Jay W. Carlson

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

BJC Outpatient Center at Sunset Hills

Recruiting

Sunset Hills, Missouri, United States, 63127

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Great Falls Clinic

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Hi-Line Sletten Cancer Center

Recruiting

Havre, Montana, United States, 59501

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Nirav S. Kapadia

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Michael C. Repka

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Paul P. Koffer

UH Seidman Cancer Center at UH Avon Health Center

Recruiting

Avon, Ohio, United States, 44011

Contacts

Site Public Contact

800-641-2422

Principal Investigator:

Jason Brown

UHHS-Chagrin Highlands Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Principal Investigator:

Jason Brown

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Jason Brown

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Shang-Jui Wang

UH Seidman Cancer Center at Lake Health Mentor Campus

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Principal Investigator:

Jason Brown

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Kelly L. Stratton

Mercy Hospital Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Site Public Contact

405-752-3402

Principal Investigator:

Jay W. Carlson

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Principal Investigator:

Gregory A. Masters

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

David T. Marshall

Gibbs Cancer Center-Gaffney

Recruiting

Gaffney, South Carolina, United States, 29341

Contacts

Principal Investigator:

Jeremy M. Kilburn

Self Regional Healthcare

Recruiting

Greenwood, South Carolina, United States, 29646

Contacts

Principal Investigator:

David T. Marshall

Gibbs Cancer Center-Pelham

Recruiting

Greer, South Carolina, United States, 29651

Contacts

Principal Investigator:

Jeremy M. Kilburn

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Principal Investigator:

Jeremy M. Kilburn

SMC Center for Hematology Oncology Union

Recruiting

Union, South Carolina, United States, 29379

Contacts

Principal Investigator:

Jeremy M. Kilburn

Vanderbilt Breast Center at One Hundred Oaks

Recruiting

Nashville, Tennessee, United States, 37204

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Austin N. Kirschner

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Austin N. Kirschner

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Principal Investigator:

Comron Hassanzadeh

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Xingzhe Li

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Xingzhe Li

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Comron Hassanzadeh

MD Anderson West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Principal Investigator:

Comron Hassanzadeh

MD Anderson League City

Recruiting

League City, Texas, United States, 77573

Contacts

Principal Investigator:

Comron Hassanzadeh

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Principal Investigator:

Comron Hassanzadeh

Bon Secours Memorial Regional Medical Center

Recruiting

Mechanicsville, Virginia, United States, 23116

Contacts

Principal Investigator:

Joseph D. Pennington

Bon Secours Saint Francis Medical Center

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Principal Investigator:

Joseph D. Pennington

Bon Secours Saint Mary's Hospital

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Principal Investigator:

Joseph D. Pennington

Bon Secours Cancer Institute at Reynolds Crossing

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Principal Investigator:

Joseph D. Pennington

Langlade Hospital and Cancer Center

Recruiting

Antigo, Wisconsin, United States, 54409

Contacts

Principal Investigator:

Andrew J. Huang

Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, United States, 54017

Contacts

Principal Investigator:

Charles Shideman

Aspirus Cancer Care - James Beck Cancer Center

Recruiting

Rhinelander, Wisconsin, United States, 54501

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54481

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Regional Cancer Center

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Site Public Contact

877-405-6866

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Wisconsin Rapids

Recruiting

Wisconsin Rapids, Wisconsin, United States, 54494

Contacts

Site Public Contact

715-422-7718

Principal Investigator:

Andrew J. Huang

Memorial Hospital of Laramie County

Recruiting

Cheyenne, Wyoming, United States, 82001

Contacts

Principal Investigator:

John M. Schallenkamp

More Information

Sponsor

NRG Oncology

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-08-18.