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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: NRG Oncology • ClinicalTrials.gov ID: NCT07097142

Registry updated: 2026-08-18
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood, tissue, and urine sample collection
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT scan
  • Fluorouracil (Drug)
    Given IV
  • Gemcitabine (Drug)
    Given IV
  • Hypofractionated Radiation Therapy (Radiation)
    Undergo hypofractionated radiation therapy
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Mitomycin (Drug)
    Given IV
  • Positron Emission Tomography (Procedure)
    Undergo PET scan
  • Survey Administration (Other)
    Ancillary studies
  • Ultrahypofractionated Radiation Therapy (Radiation)
    Undergo ultrahypofractionated radiation therapy.

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

Conditions

Muscle Invasive Bladder Urothelial Carcinoma Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record