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NCT07000084 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT07000084: Recruiting Phase 3 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT07000084 is a Phase 3 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8 that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 330 participants, above the 199-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (66% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07000084, a Phase 3 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
HG-RFS will be calculated from randomization until the detection of a high-grade bladder cancer recurrence (biopsy proven intravesical recurrence or distant metastasis), cystectomy, or death, whichever occurs first. Patients who are alive and without documented high-grade recurrence will be censored at the time of last disease evaluation. HG-RFS will be compared between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corres
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL BCG Solution
- PROCEDURE Cystoscopy
- PROCEDURE Biopsy of Bladder
Study Locations (20)
Illinois
- Northwestern University - Chicago
- University of Illinois - Chicago
- Loyola University Medical Center - Maywood
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb - Melrose Park
Indiana
- IU Health West Hospital - Avon
- IU Health North Hospital - Carmel
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
- IU Health Methodist Hospital - Indianapolis
Idaho
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital in Arizona - Phoenix
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Mayo Clinic in Florida - Jacksonville
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2025-07-17 |
| Est. Completion | 2028-12-05 |
| Phase | Phase 3 |
What NCT07000084 shows while recruiting
NCT07000084 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 199-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (66% higher).
The record links to 3 conditions, with Stage 0a Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT07000084 names 20 study sites across 9 states, led by Illinois, Indiana, Idaho.
Frequently Asked Questions
What is clinical trial NCT07000084 about?
NCT07000084 is a clinical study titled "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". 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...
What is the current status of trial NCT07000084?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2025-07-17. Estimated completion is 2028-12-05.
What conditions does trial NCT07000084 study?
This clinical trial studies the following conditions: Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Recurrent Non-Muscle Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT07000084?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), BCG Solution (BIOLOGICAL), Cystoscopy (PROCEDURE), Biopsy of Bladder (PROCEDURE).
Who is sponsoring clinical trial NCT07000084?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07000084 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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