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RECRUITING 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

NCT07000084 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 330 participants
Start Date 2025-07-17
Est. Completion 2028-12-05
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07000084

The ClinicalTrials.gov registry entry for NCT07000084 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07000084 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Illinois, Indiana, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07000084?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial