🔎 Trials Near Me

Home › Bladder Cancer › NCT07097142

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

RecruitingPhase 3

The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: NRG Oncology · Participants: 486 · Started: Oct 7, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07097142

Locations in the U.S.

ArkansasMercy Hospital Fort Smith, Fort Smith
CaliforniaUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
UC San Diego Moores Cancer Center, La Jolla
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
University of California Davis Comprehensive Cancer Center, Sacramento
ColoradoUCHealth University of Colorado Hospital, Aurora
UCHealth - Cherry Creek, Denver
UCHealth Highlands Ranch Hospital, Highlands Ranch
UCHealth Lone Tree Health Center, Lone Tree
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Christiana Care Health System-Wilmington Hospital, Wilmington
FloridaUM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral, Doral
Miami Cancer Institute, Miami
UM Sylvester Comprehensive Cancer Center at Kendall, Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia, North Miami
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
IdahoKootenai Health - Coeur d'Alene, Coeur d'Alene
Kootenai Clinic Cancer Services - Post Falls, Post Falls
IllinoisOSF Saint Anthony's Health Center, Alton
Illinois CancerCare-Bloomington, Bloomington
OSF Saint Joseph Medical Center, Bloomington
Illinois CancerCare-Canton, Canton
Memorial Hospital of Carbondale, Carbondale
SIH Cancer Institute, Carterville
Illinois CancerCare-Carthage, Carthage
Centralia Oncology Clinic, Centralia
Northwestern University, Chicago
Rush MD Anderson Cancer Center, Chicago
University of Illinois, Chicago
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Crossroads Cancer Center, Effingham
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Illinois CancerCare-Kewanee Clinic, Kewanee
Illinois CancerCare-Macomb, Macomb
SSM Health Good Samaritan, Mount Vernon
Cancer Care Center of O'Fallon, O'Fallon
HSHS Saint Elizabeth's Hospital, O'Fallon
Rush MD Anderson Cancer Center at Rush Oak Park, Oak Park
Northwestern Medicine Orland Park, Orland Park
Illinois CancerCare-Ottawa Clinic, Ottawa
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
OSF Saint Francis Medical Center, Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Illinois CancerCare - Washington, Washington
IowaUI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
Mercy Cancer Center-West Lakes, Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive
Greater Regional Medical Center, Creston
Iowa Methodist Medical Center, Des Moines
Mercy Medical Center - Des Moines, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
Mercy Medical Center-West Lakes, West Des Moines
The Iowa Clinic PC, West Des Moines
KansasCentral Care Cancer Center - Garden City, Garden City
University of Kansas Cancer Center, Kansas City
University of Kansas Cancer Center-Overland Park, Overland Park
Mercy Hospital Pittsburg, Pittsburg
University of Kansas Health System Saint Francis Campus, Topeka
University of Kansas Hospital-Westwood Cancer Center, Westwood
Ascension Via Christi Hospitals Wichita, Wichita
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington (Not yet recruiting)
LouisianaLouisiana Hematology Oncology Associates LLC, Baton Rouge
Mary Bird Perkins Cancer Center, Baton Rouge
Mary Bird Perkins Cancer Center - Metairie, Metairie
MassachusettsMassachusetts General Hospital Cancer Center, Boston
MichiganUniversity of Michigan Rogel Cancer Center, Ann Arbor
Bronson Battle Creek, Battle Creek
University of Michigan - Brighton Center for Specialty Care, Brighton
Henry Ford Cancer Institute-Downriver, Brownstown
Henry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Medical Center-Fairlane, Dearborn
Henry Ford Hospital, Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Trinity Health Grand Rapids Hospital, Grand Rapids
Allegiance Health, Jackson
Beacon Kalamazoo, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores
Henry Ford Medical Center-Columbus, Novi
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Munson Medical Center, Traverse City
Henry Ford West Bloomfield Hospital, West Bloomfield
Henry Ford Wyandotte Hospital, Wyandotte
University of Michigan Health - West, Wyoming
MinnesotaMinnesota Oncology - Burnsville, Burnsville
Mercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Fairview Clinics and Surgery Center Maple Grove, Maple Grove
Minnesota Oncology Hematology PA-Maplewood, Maplewood
Saint John's Hospital - Healtheast, Maplewood
Abbott-Northwestern Hospital, Minneapolis
Hennepin County Medical Center, Minneapolis
Monticello Cancer Center, Monticello
North Memorial Medical Health Center, Robbinsdale
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Saint Francis Regional Medical Center, Shakopee
Lakeview Hospital, Stillwater
Ridgeview Medical Center, Waconia
Rice Memorial Hospital, Willmar
Minnesota Oncology Hematology PA-Woodbury, Woodbury
MissouriCentral Care Cancer Center - Bolivar, Bolivar
Mercy Cancer Center - Cape Girardeau, Cape Girardeau
Saint Francis Medical Center, Cape Girardeau
MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia
Parkland Health Center - Farmington, Farmington
Freeman Health System, Joplin
Mercy Hospital Joplin, Joplin
University of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
Lake Regional Hospital, Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology, Rolla
Phelps Health Delbert Day Cancer Institute, Rolla
Heartland Regional Medical Center, Saint Joseph
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
CoxHealth South Hospital, Springfield
Mercy Hospital Springfield, Springfield
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Missouri Baptist Medical Center, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
BJC Outpatient Center at Sunset Hills, Sunset Hills
MontanaBillings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Hi-Line Sletten Cancer Center, Havre
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyMemorial Sloan Kettering Basking Ridge, Basking Ridge
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
New YorkMemorial Sloan Kettering Commack, Commack
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Cancer Center, New York
Highland Hospital, Rochester (Not yet recruiting)
University of Rochester, Rochester (Not yet recruiting)
Memorial Sloan Kettering Nassau, Uniondale
Wilmot Cancer Institute at Webster, Webster (Not yet recruiting)
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke University Medical Center, Durham
OhioUH Seidman Cancer Center at UH Avon Health Center, Avon
UHHS-Chagrin Highlands Medical Center, Beachwood
Case Western Reserve University, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor
OklahomaMercy Hospital Oklahoma City, Oklahoma City
University of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaChristiana Care Health System-Concord Health Center, Chadds Ford
South CarolinaMedical University of South Carolina, Charleston
Gibbs Cancer Center-Gaffney, Gaffney
Self Regional Healthcare, Greenwood
Gibbs Cancer Center-Pelham, Greer
Spartanburg Medical Center, Spartanburg
SMC Center for Hematology Oncology Union, Union
TennesseeVanderbilt Breast Center at One Hundred Oaks, Nashville
Vanderbilt University/Ingram Cancer Center, Nashville
TexasMD Anderson in The Woodlands, Conroe
Parkland Memorial Hospital, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
M D Anderson Cancer Center, Houston
MD Anderson West Houston, Houston
MD Anderson League City, League City
MD Anderson in Sugar Land, Sugar Land
VirginiaBon Secours Memorial Regional Medical Center, Mechanicsville
Bon Secours Saint Francis Medical Center, Midlothian
Bon Secours Cancer Institute at Reynolds Crossing, Richmond
Bon Secours Saint Mary's Hospital, Richmond
WisconsinLanglade Hospital and Cancer Center, Antigo
Cancer Center of Western Wisconsin, New Richmond
Aspirus Cancer Care - James Beck Cancer Center, Rhinelander
Aspirus Cancer Care - Stevens Point, Stevens Point
Aspirus Regional Cancer Center, Wausau
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids
WyomingMemorial Hospital of Laramie County, Cheyenne

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.