NCT07097142

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P50-P75 for phase_3

Timeline
50mo left

Started Oct 2025

Longer than P75 for phase_3

Geographic Reach
1 country

211 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Oct 2025May 2030

First Submitted

Initial submission to the registry

July 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

July 21, 2025

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bladder-intact event-free survival (BI-EFS)

    Defined as histologically proven presence of muscle invasive bladder cancer (MIBC), radiographic evidence of nodal or metastatic disease, performance of radical cystectomy, or death from any cause. Time to event will be calculated from the date of randomization. BI-EFS will be estimated in the two treatment groups using the Kaplan-Meier method and the hazard ratio between ultra-hypofractionation and hypofractionation estimated by fitting a Cox proportional hazards regression model, including a treatment arm indicator variable and adjusting for the three stratification factors employed in the randomization.

    Up to 3 years

Secondary Outcomes (8)

  • Incidence of urinary adverse events

    Up to year 2

  • Incidence of bowel adverse events

    Up to year 2

  • Quality of life

    At baseline, 4 weeks, 16 weeks, 13 months, 25 months, and 37 months

  • Event free survival

    From randomization to histologically proven presence of MIBC, radiographic evidence of nodal or metastatic disease, or death from any cause, up to 5 years

  • Metastasis-free survival

    From randomization to radiographic evidence of metastatic disease or death due to any cause, up to 5 years

  • +3 more secondary outcomes

Other Outcomes (6)

  • ctDNA

    At baseline, 4, 16, 28, 40, and 56 weeks from start of chemotherapy

  • Tissue free minimal residual disease

    At time of progression

  • Urine tumor deoxyribonucleic acid

    At baseline, 4, 16, 28, 40, and 56 weeks from start of chemotherapy

  • +3 more other outcomes

Study Arms (2)

Arm I (hypofractionated radiation therapy)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen CollectionDrug: CisplatinProcedure: Computed TomographyDrug: FluorouracilDrug: GemcitabineRadiation: Hypofractionated Radiation TherapyProcedure: Magnetic Resonance ImagingDrug: MitomycinProcedure: Positron Emission TomographyOther: Survey Administration

Arm II (Ultrahypofractionated radiation therapy)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionDrug: CisplatinProcedure: Computed TomographyDrug: FluorouracilDrug: GemcitabineProcedure: Magnetic Resonance ImagingDrug: MitomycinProcedure: Positron Emission TomographyOther: Survey AdministrationRadiation: Ultrahypofractionated Radiation Therapy

Interventions

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Given IV

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Undergo blood, tissue, and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Arm I (hypofractionated radiation therapy)

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Given IV

Also known as: Ametycine, Jelmyto, MITO, Mito-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin pyelocalyceal, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Ancillary studies

Arm I (hypofractionated radiation therapy)Arm II (Ultrahypofractionated radiation therapy)

Undergo ultrahypofractionated radiation therapy.

Also known as: Ultrahypofractionated Radiotherapy
Arm II (Ultrahypofractionated radiation therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (211)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth - Cherry Creek

Denver, Colorado, 80206, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124, United States

RECRUITING

Beebe Medical Center

Lewes, Delaware, 19958, United States

RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, 33166, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

RECRUITING

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, 33181, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

RECRUITING

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

RECRUITING

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

RECRUITING

SIH Cancer Institute

Carterville, Illinois, 62918, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

SUSPENDED

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

Rush MD Anderson Cancer Center at Rush Oak Park

Oak Park, Illinois, 60304, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

RECRUITING

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Valley Radiation Oncology

Peru, Illinois, 61354, United States

SUSPENDED

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

RECRUITING

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

Clive, Iowa, 50325, United States

RECRUITING

Greater Regional Medical Center

Creston, Iowa, 50801, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

RECRUITING

The Iowa Clinic PC

West Des Moines, Iowa, 50266, United States

RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

RECRUITING

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530, United States

SUSPENDED

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States

RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

NOT YET RECRUITING

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

RECRUITING

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

RECRUITING

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

RECRUITING

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

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

Grand Rapids, Michigan, 49503, United States

RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Allegiance Health

Jackson, Michigan, 49201, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Beacon Kalamazoo

Kalamazoo, Michigan, 49048, United States

RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States

RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444, United States

RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

RECRUITING

Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States

RECRUITING

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

RECRUITING

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States

RECRUITING

Munson Medical Center

Traverse City, Michigan, 49684, United States

RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

RECRUITING

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, 48192, United States

RECRUITING

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369, United States

RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

RECRUITING

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

RECRUITING

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

RECRUITING

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

RECRUITING

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

RECRUITING

Freeman Health System

Joplin, Missouri, 64804, United States

RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

RECRUITING

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, 64116, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

RECRUITING

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Hospital South

St Louis, Missouri, 63128, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

RECRUITING

Great Falls Clinic

Great Falls, Montana, 59405, United States

RECRUITING

Hi-Line Sletten Cancer Center

Havre, Montana, 59501, United States

RECRUITING

Logan Health Medical Center

Kalispell, Montana, 59901, United States

RECRUITING

Community Medical Center

Missoula, Montana, 59804, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Highland Hospital

Rochester, New York, 14620, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14642, United States

NOT YET RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, 14580, United States

NOT YET RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011, United States

RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

RECRUITING

Self Regional Healthcare

Greenwood, South Carolina, 29646, United States

RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

SMC Center for Hematology Oncology Union

Union, South Carolina, 29379, United States

RECRUITING

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

RECRUITING

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MD Anderson West Houston

Houston, Texas, 77079, United States

RECRUITING

MD Anderson League City

League City, Texas, 77573, United States

RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

RECRUITING

Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23226, United States

RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230, United States

RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

RECRUITING

Memorial Hospital of Laramie County

Cheyenne, Wyoming, 82001, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Specimen HandlingCisplatin1,2-diaminocyclohexaneplatinum II citratePlatinumFluorouracildehydroftorafurGemcitabineRadiation Dose HypofractionationRadiationMagnetic Resonance SpectroscopyMitomycinMitozytrex

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesDose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeuticsPhysical PhenomenaSpectrum AnalysisChemistry Techniques, AnalyticalMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Scott E Delacroix

    NRG Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 31, 2025

Study Start

October 7, 2025

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

More information

Locations