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GAIN-BCG: Gemcitabine Alternating with INtravesical BCG Randomized Against BCG Alone for Patients with Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Short Title: A032303

Enrollment Status: Recruiting

NCT #: NCT07000084

Specialty Area: Oncology

Condition Studied: Non-Muscle Invasive Bladder Cancer

Age Groups: Adult; Older Adult

Phase: III

Study Information

Summary / Purpose

The purpose of this study is to find out whether adding gemcitabine to the usual treatment, Bacillus Calmette-Guérin (BCG), works better than BCG alone for people with non-muscle invasive bladder cancer (NMIBC) that has come back. Both medications are given intravesically, meaning through a small tube placed directly into the bladder.

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adults 18+ years of age
Confirmed urothelial carcinoma
Must have BCG-Exposed NMIBC

What's Involved

Participation in the study will include:

Random assignment to receive either Bacillus Calmette-Guérin (BCG) alone, the usual treatment, or BCG alternating with gemcitabine
BCG solution placed directly into the bladder through a catheter
Gemcitabine placed directly into the bladder, for participants assigned to that group
Cystoscopy, a procedure that uses a thin camera to look inside the bladder
Bladder biopsies and transurethral resection of bladder tumor (TURBT), a procedure to remove tissue from the bladder
Blood and urine sample collection
Imaging with computed tomography (CT) scans and magnetic resonance imaging (MRI) scans

Principal Investigator

Shi-Ming Tu, MD

Hematology - Oncology

Renown Hematology/Oncology

(775) 982–5000

View Provider

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT07000084

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.