Taking people in United StatesPhase 3
Shorter Radiation Schedule With Chemotherapy for Muscle-Invasive Bladder Cancer
Tests a shorter course of radiation with chemotherapy in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
Key facts
- Where
- Akron, Alton, Ankeny, Ann Arbor, Antigo, Atlanta, Aurora, Avon, Basking Ridge, Baton Rouge, Battle Creek, Beachwood, Beverly Hills, Billings, Bloomington, Bolivar, Boston, Bozeman, Brighton, Brownstown, Burnsville, Canton, Cape Girardeau, Carbondale, Carterville, Carthage, Cary, Centralia, Chadds Ford, Chapel Hill, Charleston, Chaska, Cheyenne, Chicago, Cleveland, Clinton Township, Clive, Coeur d'Alene, Columbia, Columbus, Commack, Conroe, Coon Rapids, Coral Gables, Creston, Dallas, Danville, Dearborn, Decatur, Deerfield Beach, Denver, Des Moines, Detroit, Dickson City, Dixon, Doral, Durham, Edina, Effingham, Elmhurst, Eureka, Fairbanks, Farmington, Farmington Hills, Fort Smith, Gaffney, Galesburg, Garden City, Grand Rapids, Great Bend, Great Falls, Greenwood, Greer, Harrison, Havre, Hazleton, Hershey, Highlands Ranch, Houston, Irvine, Jackson, Joplin, Kalamazoo, Kalispell, Kansas City, Kewanee, La Jolla, Lawrence, League City, Lebanon, Lee's Summit, Lewes, Lewisburg, Lexington, Lisle, Little Rock, Littleton, Lone Tree, Los Angeles, Macomb, Maple Grove, Maplewood, Mattoon, Mayfield Heights, Mechanicsville, Mentor, Metairie, Miami, Middletown, Midlothian, Millville, Minneapolis, Missoula, Monticello, Montvale, Morgantown, Mount Vernon, Muskegon, Naperville, Nashville, New Richmond, New York, Newark, Niles, North Miami, Norton Shores, Novi, O'Fallon, Oak Park, Oklahoma City, Orange, Orland Park, Osage Beach, Ottawa, Overland Park, Parker, Parkersburg, Pekin, Peoria, Peru, Pittsburg, Plantation, Post Falls, Princeton, Raleigh, Reed City, Rehoboth Beach, Reno, Rhinelander, Richmond, Robbinsdale, Rochester, Rolla, Royal Oak, Sacramento, Saint Cloud, Saint Joseph, Saint Louis Park, Saint Paul, Sainte Genevieve, Shakopee, Spartanburg, Springfield, St Louis, Stevens Point, Stillwater, Strongsville, Sugar Land, Sullivan, Tarzana, Temple, Topeka, Torrance, Traverse City, Troy, Union, Uniondale, Urbana, Waconia, Washington, Waukee, Wausau, Webster, West Bloomfield, West Des Moines, Westwood, Wheeling, Wichita, Wilkes-Barre, Willmar, Wilmington, Wisconsin Rapids, Woodbury, Wyandotte, and Wyoming, United StatesSee the 258 sites
- Phase
- Phase 3
Where in United States
- Cleveland Clinic Akron GeneralAkron, United StatesTaking people
- OSF Saint Anthony's Health CenterAlton, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
- Aspirus Cancer Care-Antigo-Volm Cancer CenterAntigo, United StatesTaking people
- Emory Saint Joseph's HospitalAtlanta, United StatesTaking people
- Emory University Hospital MidtownAtlanta, United StatesTaking people
- Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesTaking people
- Grady Health SystemAtlanta, United StatesTaking people
- UCHealth University of Colorado HospitalAurora, United StatesTaking people
- UH Seidman Cancer Center at UH Avon Health CenterAvon, United StatesTaking people
- Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
- Louisiana Hematology Oncology Associates LLCBaton Rouge, United StatesTaking people
- Mary Bird Perkins Cancer CenterBaton Rouge, United StatesTaking people
- Bronson Battle CreekBattle Creek, United StatesTaking people
- UHHS-Chagrin Highlands Medical CenterBeachwood, United StatesTaking people
- Tower Cancer Research FoundationBeverly Hills, United StatesTaking people
- Billings Clinic Cancer CenterBillings, United StatesTaking people
- Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
- OSF Saint Joseph Medical CenterBloomington, United StatesTaking people
- Central Care Cancer Center - BolivarBolivar, United StatesTaking people
- Massachusetts General Hospital Cancer CenterBoston, United StatesTaking people
- Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
- University of Michigan - Brighton Center for Specialty CareBrighton, United StatesTaking people
- Henry Ford Cancer Institute-DownriverBrownstown, United StatesTaking people
- Minnesota Oncology - BurnsvilleBurnsville, United StatesTaking people
- Illinois CancerCare-CantonCanton, United StatesTaking people
- Mercy Cancer Center - Cape GirardeauCape Girardeau, United StatesTaking people
- Saint Francis Medical CenterCape Girardeau, United StatesTaking people
- Memorial Hospital of CarbondaleCarbondale, United StatesTaking people
- SIH Cancer InstituteCarterville, United StatesTaking people
- Illinois CancerCare-CarthageCarthage, United StatesTaking people
- Duke Cancer Center CaryCary, United StatesTaking people
- Centralia Oncology ClinicCentralia, United StatesTaking people
- Christiana Care Health System-Concord Health CenterChadds Ford, United StatesTaking people
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Minnesota Oncology Hematology PA-ChaskaChaska, United StatesTaking people
- Memorial Hospital of Laramie CountyCheyenne, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Rush MD Anderson Cancer CenterChicago, United StatesTaking people
- University of IllinoisChicago, United StatesNo longer taking part
- Case Western Reserve UniversityCleveland, United StatesTaking people
- Cleveland Clinic Cancer Center/Fairview HospitalCleveland, United StatesTaking people
- Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesTaking people
- Mercy Cancer Center-West LakesClive, United StatesTaking people
- UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
- Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
- MU Health - University Hospital/Ellis Fischel Cancer CenterColumbia, United StatesTaking people
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
- Memorial Sloan Kettering CommackCommack, United StatesTaking people
- UT MD Anderson - The WoodlandsConroe, United StatesTaking people
- Mercy HospitalCoon Rapids, United StatesTaking people
- Minnesota Oncology - Coon RapidsCoon Rapids, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United StatesTaking people
- Greater Regional Medical CenterCreston, United StatesNo longer taking part
- Parkland Memorial HospitalDallas, United StatesTaking people
- UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
- Carle at The RiverfrontDanville, United StatesTaking people
- Geisinger Medical CenterDanville, United StatesTaking people
- Corewell Health Dearborn HospitalDearborn, United StatesTaking people
- Henry Ford Medical Center-FairlaneDearborn, United StatesTaking people
- Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
- Decatur Memorial HospitalDecatur, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesTaking people
- AdventHealth PorterDenver, United StatesTaking people
- UCHealth - Cherry CreekDenver, United StatesTaking people
- Iowa Methodist Medical CenterDes Moines, United StatesTaking people
- Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Wayne State University/Karmanos Cancer InstituteDetroit, United StatesTaking people
- Geisinger Cancer Center Dickson CityDickson City, United StatesTaking people
- Illinois CancerCare-DixonDixon, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at DoralDoral, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- Fairview Southdale HospitalEdina, United StatesTaking people
- Minnesota Oncology - EdinaEdina, United StatesTaking people
- Carle Physician Group-EffinghamEffingham, United StatesTaking people
- Crossroads Cancer CenterEffingham, United StatesTaking people
- Elmhurst Memorial HospitalElmhurst, United StatesTaking people
- Illinois CancerCare-EurekaEureka, United StatesTaking people
- Fairbanks Memorial HospitalFairbanks, United StatesTaking people
- Parkland Health Center - FarmingtonFarmington, United StatesTaking people
- Weisberg Cancer Treatment CenterFarmington Hills, United StatesTaking people
- Corewell Health Farmington Hills HospitalFarmington Hills, United StatesNo longer taking part
- Mercy Hospital Fort SmithFort Smith, United StatesTaking people
- Gibbs Cancer Center-GaffneyGaffney, United StatesTaking people
- Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
- Central Care Cancer Center - Garden CityGarden City, United StatesTaking people
- Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesTaking people
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
- Trinity Health Grand Rapids HospitalGrand Rapids, United StatesNo longer taking part
- Central Care Cancer Center - Great BendGreat Bend, United StatesNo longer taking part
- Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
- Great Falls ClinicGreat Falls, United StatesTaking people
- Self Regional HealthcareGreenwood, United StatesTaking people
- Gibbs Cancer Center-PelhamGreer, United StatesTaking people
- Memorial Sloan Kettering WestchesterHarrison, United StatesTaking people
- Hi-Line Sletten Cancer CenterHavre, United StatesTaking people
- Geisinger Medical Center-Cancer Center HazletonHazleton, United StatesTaking people
- Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
- UCHealth Highlands Ranch HospitalHighlands Ranch, United StatesTaking people
- UT MD Anderson - West HoustonHouston, United StatesTaking people
- UT MD Anderson Cancer CenterHouston, United StatesTaking people
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesTaking people
- Allegiance HealthJackson, United StatesTaking people
- Freeman Health SystemJoplin, United StatesTaking people
- Mercy Hospital JoplinJoplin, United StatesTaking people
- Bronson Methodist HospitalKalamazoo, United StatesTaking people
- West Michigan Cancer CenterKalamazoo, United StatesTaking people
- Beacon KalamazooKalamazoo, United StatesNo longer taking part
- Logan Health Medical CenterKalispell, United StatesTaking people
- University of Kansas Cancer CenterKansas City, United StatesTaking people
- University of Kansas Cancer Center - BriarcliffKansas City, United StatesTaking people
- University of Kansas Cancer Center - NorthKansas City, United StatesTaking people
- Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
- UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- Lawrence Memorial HospitalLawrence, United StatesTaking people
- UT MD Anderson - League CityLeague City, United StatesTaking people
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
- University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesTaking people
- Beebe Medical CenterLewes, United StatesTaking people
- Geisinger Medical Oncology-LewisburgLewisburg, United StatesTaking people
- University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
- Rush MD Anderson Cancer Center at Rush LisleLisle, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- AdventHealth LittletonLittleton, United StatesTaking people
- UCHealth Lone Tree Health CenterLone Tree, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, United StatesTaking people
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- Illinois CancerCare-MacombMacomb, United StatesTaking people
- Fairview Clinics and Surgery Center Maple GroveMaple Grove, United StatesTaking people
- Minnesota Oncology - Maple GroveMaple Grove, United StatesTaking people
- Minnesota Oncology Hematology PA-MaplewoodMaplewood, United StatesTaking people
- Saint John's Hospital - HealtheastMaplewood, United StatesTaking people
- Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
- Hillcrest Hospital Cancer CenterMayfield Heights, United StatesTaking people
- Bon Secours Memorial Regional Medical CenterMechanicsville, United StatesTaking people
- UH Seidman Cancer Center at Lake Health Mentor CampusMentor, United StatesTaking people
- Mary Bird Perkins Cancer Center - MetairieMetairie, United StatesTaking people
- Miami Cancer InstituteMiami, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at KendallMiami, United StatesTaking people
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
- Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
- Bon Secours Saint Francis Medical CenterMidlothian, United StatesTaking people
- Beebe South Coastal Health CampusMillville, United StatesTaking people
- Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
- Hennepin County Medical CenterMinneapolis, United StatesTaking people
- Community Medical CenterMissoula, United StatesTaking people
- Monticello Cancer CenterMonticello, United StatesTaking people
- Memorial Sloan Kettering BergenMontvale, United StatesTaking people
- West Virginia University HealthcareMorgantown, United StatesTaking people
- SSM Health Good SamaritanMount Vernon, United StatesTaking people
- Trinity Health Muskegon HospitalMuskegon, United StatesNo longer taking part
- Edward Hospital/Cancer CenterNaperville, United StatesTaking people
- Vanderbilt Breast Center at One Hundred OaksNashville, United StatesTaking people
- Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
- Cancer Center of Western WisconsinNew Richmond, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesTaking people
- Christiana Care Health System-Christiana HospitalNewark, United StatesTaking people
- Helen F Graham Cancer CenterNewark, United StatesTaking people
- Medical Oncology Hematology Consultants PANewark, United StatesTaking people
- Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesTaking people
- University of Miami Sylvester Comprehensive Cancer Center at Sole MiaNorth Miami, United StatesTaking people
- Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesNo longer taking part
- Henry Ford Medical Center-ColumbusNovi, United StatesTaking people
- Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
- HSHS Saint Elizabeth's HospitalO'Fallon, United StatesTaking people
- Rush MD Anderson Cancer Center at Rush Oak ParkOak Park, United StatesTaking people
- Mercy Hospital Oklahoma CityOklahoma City, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
- UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United StatesTaking people
- Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
- Lake Regional HospitalOsage Beach, United StatesTaking people
- Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
- University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
- AdventHealth ParkerParker, United StatesTaking people
- Camden Clark Medical CenterParkersburg, United StatesTaking people
- Illinois CancerCare-PekinPekin, United StatesTaking people
- Illinois CancerCare-PeoriaPeoria, United StatesTaking people
- Methodist Medical Center of IllinoisPeoria, United StatesTaking people
- OSF Saint Francis Medical CenterPeoria, United StatesTaking people
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterPeoria, United StatesTaking people
- Illinois CancerCare-PeruPeru, United StatesTaking people
- Valley Radiation OncologyPeru, United StatesNo longer taking part
- Mercy Hospital PittsburgPittsburg, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United StatesTaking people
- Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
- Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
- Duke Cancer Center RaleighRaleigh, United StatesTaking people
- UNC Health Cancer Care RaleighRaleigh, United StatesTaking people
- Corewell Health Reed City HospitalReed City, United StatesTaking people
- Beebe Health CampusRehoboth Beach, United StatesTaking people
- Renown Regional Medical CenterReno, United StatesTaking people
- Aspirus Cancer Care-Rhinelander-James Beck Cancer CenterRhinelander, United StatesTaking people
- Bon Secours Cancer Institute at Reynolds CrossingRichmond, United StatesTaking people
- Bon Secours Saint Mary's HospitalRichmond, United StatesTaking people
- North Memorial Medical Health CenterRobbinsdale, United StatesTaking people
- Highland HospitalRochester, United StatesNot yet recruiting
- University of RochesterRochester, United StatesTaking people
- Mercy Clinic-Rolla-Cancer and HematologyRolla, United StatesTaking people
- Phelps Health Delbert Day Cancer InstituteRolla, United StatesTaking people
- Corewell Health William Beaumont University HospitalRoyal Oak, United StatesTaking people
- University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
- Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesTaking people
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesTaking people
- Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesTaking people
- Heartland Regional Medical CenterSaint Joseph, United StatesTaking people
- Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
- Regions HospitalSaint Paul, United StatesTaking people
- United HospitalSaint Paul, United StatesTaking people
- Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesTaking people
- Saint Francis Regional Medical CenterShakopee, United StatesTaking people
- Spartanburg Medical CenterSpartanburg, United StatesTaking people
- CoxHealth South HospitalSpringfield, United StatesTaking people
- Mercy Hospital SpringfieldSpringfield, United StatesTaking people
- Southern Illinois University School of MedicineSpringfield, United StatesTaking people
- Springfield ClinicSpringfield, United StatesTaking people
- Springfield Memorial HospitalSpringfield, United StatesTaking people
- Mercy Hospital Saint LouisSt Louis, United StatesTaking people
- Mercy Hospital SouthSt Louis, United StatesTaking people
- Missouri Baptist Medical CenterSt Louis, United StatesTaking people
- Aspirus Cancer Care - Stevens PointStevens Point, United StatesTaking people
- Lakeview HospitalStillwater, United StatesTaking people
- Cleveland Clinic Cancer Center StrongsvilleStrongsville, United StatesTaking people
- UT MD Anderson - Sugar LandSugar Land, United StatesTaking people
- Missouri Baptist Sullivan HospitalSullivan, United StatesTaking people
- Cedars-Sinai Cancer - TarzanaTarzana, United StatesTaking people
- Scott and White Memorial HospitalTemple, United StatesTaking people
- University of Kansas Health System Saint Francis CampusTopeka, United StatesTaking people
- Torrance Memorial Physician Network - Cancer CareTorrance, United StatesTaking people
- Munson Medical CenterTraverse City, United StatesTaking people
- Corewell Health Beaumont Troy HospitalTroy, United StatesTaking people
- SMC Center for Hematology Oncology UnionUnion, United StatesTaking people
- Memorial Sloan Kettering NassauUniondale, United StatesTaking people
- Carle Cancer CenterUrbana, United StatesTaking people
- Ridgeview Medical CenterWaconia, United StatesTaking people
- Illinois CancerCare - WashingtonWashington, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
- Aspirus Cancer Care-WausauWausau, United StatesTaking people
- Wilmot Cancer Institute at WebsterWebster, United StatesNot yet recruiting
- Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesTaking people
- Mercy Medical Center-West LakesWest Des Moines, United StatesTaking people
- The Iowa Clinic PCWest Des Moines, United StatesTaking people
- University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
- Wheeling Hospital/Schiffler Cancer CenterWheeling, United StatesTaking people
- Ascension Via Christi Hospitals WichitaWichita, United StatesTaking people
- Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesTaking people
- Rice Memorial HospitalWillmar, United StatesTaking people
- Christiana Care Health System-Wilmington HospitalWilmington, United StatesTaking people
- Aspirus Cancer Care - Wisconsin RapidsWisconsin Rapids, United StatesTaking people
- Minnesota Oncology Hematology PA-WoodburyWoodbury, United StatesTaking people
- Henry Ford Wyandotte HospitalWyandotte, United StatesTaking people
- University of Michigan Health - WestWyoming, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NRG Oncology
- Trial code
- NCT07097142
- Record updated
- 23 October 2026
- Original 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.Read full original descriptionShow less
The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)
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.
Inclusion: 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 ≥3 cycles of neoadjuvant chemotherapy prior to randomization, this eligibility window from diagnosis (TURBT Path) to enrollment is extended to 240 days before randomization. It remains a 180 day window for all others; 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.