RecruitingPhase IIIEN original

Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rak pęcherza moczowego (określony jako wysoki stopień złośliwości, powracający po leczeniu).
  • Wszystkie widoczne guzy o charakterze brodawkowatym usunięte w ciągu ostatnich 90 dni przed rozpoczęciem badania.
  • Jeśli guz nie został usunięty przez urologa prowadzącego leczenie, konieczne jest badanie wziernikiem pęcherza w ciągu ostatnich 45 dni.
  • Pacjenci z guzem T1 wysokiego stopnia muszą przejść ponowne badanie w ciągu 90 dni przed rozpoczęciem badania.
  • Rak pęcherza, który powrócił w ciągu 24 miesięcy od ostatniego leczenia BCG.

✗ Disqualifies

  • Obecność raka z komponentem neuroendokrynnym (np. drobnokomórkowego).
  • Czysty rak płaskonabłonkowy lub czysty gruczolakorak bez komponentu nabłonka przejściowego.
  • Nieleczony rak pęcherza moczowego.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (58)

University of Alabama at Birmingham Cancer Center

Birmingham, United States

Fairbanks Memorial Hospital

Fairbanks, United States

Banner MD Anderson Cancer Center

Gilbert, United States

Mayo Clinic Hospital in Arizona

Phoenix, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

Sibley Memorial Hospital

Washington D.C., United States

UF Health Cancer Institute - Gainesville

Gainesville, United States

Mayo Clinic in Florida

Jacksonville, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, United States

Northwestern University

Chicago, United States

University of Illinois

Chicago, United States

Loyola University Medical Center

Maywood, United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, United States

IU Health West Hospital

Avon, United States

IU Health North Hospital

Carmel, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, United States

IU Health Methodist Hospital

Indianapolis, United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, United States

FMH James M Stockman Cancer Institute

Frederick, United States

Brigham and Women's Hospital

Boston, United States

Lahey Clinic

Burlington, United States

Lahey Clinic Peabody

Peabody, United States

Mayo Clinic in Rochester

Rochester, United States

Community Hospital of Anaconda

Anaconda, United States

Billings Clinic Cancer Center

Billings, United States

Bozeman Health Deaconess Hospital

Bozeman, United States

Benefis Sletten Cancer Institute

Great Falls, United States

Great Falls Clinic

Great Falls, United States

Hi-Line Sletten Cancer Center

Havre, United States

Benefis Helena Specialty Center

Helena, United States

Logan Health Medical Center

Kalispell, United States

Community Medical Center

Missoula, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, United States

Hackensack University Medical Center

Hackensack, United States

Memorial Sloan Kettering Monmouth

Middletown, United States

Memorial Sloan Kettering Bergen

Montvale, United States

Roswell Park Cancer Institute

Buffalo, United States

Memorial Sloan Kettering Commack

Commack, United States

Memorial Sloan Kettering Westchester

Harrison, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Memorial Sloan Kettering Nassau

Uniondale, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Oklahoma Health Sciences Center

Oklahoma City, United States

Geisinger Medical Center

Danville, United States

Geisinger Cancer Center Dickson City

Dickson City, United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, United States

Fox Chase Cancer Center

Philadelphia, United States

Fox Chase Cancer Center-Rockledge

Rockledge, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, United States

Ralph H Johnson VA Medical Center

Charleston, United States

Medical University of South Carolina

Charleston, United States

VCU Massey Comprehensive Cancer Center

Richmond, United States

Memorial Hospital of Laramie County

Cheyenne, United States

Billings Clinic-Cody

Cody, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.