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NCT05538663 · ClinicalTrials.gov registry record · Phase 3

Intravesical BCG vs GEMDOCE in NMIBC

A Phase 3 study of Non-muscle Invasive Bladder Cancer, sponsored by ECOG-ACRIN Cancer Research Group.

Active
Registry status
Phase 3
Development phase
870
Enrollment target
20
Study locations

NCT05538663 is a Phase 3 study of Non-muscle Invasive Bladder Cancer that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 870 participants, above the 202-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (331% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT05538663, a Phase 3 study of Non-muscle Invasive Bladder Cancer, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
870 participants
Enrollment target
20
Study locations

Study Summary

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

Conditions Studied

Non-muscle Invasive Bladder Cancer

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine
  • DRUG Bacillus Calmette Guerin

Study Locations (20)

California

  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • Mercy Cancer Center - Carmichael - Carmichael
  • Mercy San Juan Medical Center - Carmichael
  • Mercy Cancer Center - Elk Grove - Elk Grove
  • UC San Diego Moores Cancer Center - La Jolla
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Contra Costa Regional Medical Center - Martinez
  • Mercy Cancer Center - Merced
  • Mercy Cancer Center - Rocklin - Rocklin
  • Mercy Cancer Center - Sacramento - Sacramento
  • UCSF Medical Center-Mission Bay - San Francisco
  • Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • CTCA at Western Regional Medical Center - Goodyear
  • Cancer Center at Saint Joseph's - Phoenix

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CARTI Cancer Center - Little Rock

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Alaska

  • Fairbanks Memorial Hospital - Fairbanks

Trial Details

FieldValue
Enrollment Target 870 participants
Start Date 2023-02-07
Est. Completion 2030-10
Phase Phase 3

Sponsor

ECOG-ACRIN Cancer Research Group

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05538663

The ClinicalTrials.gov registry entry for NCT05538663 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 202-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (331% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.

NCT05538663 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05538663 about?

NCT05538663 is a clinical study titled "Intravesical BCG vs GEMDOCE in NMIBC". The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test wh...

What is the current status of trial NCT05538663?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 870 participants. The study started on 2023-02-07. Estimated completion is 2030-10.

What conditions does trial NCT05538663 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.

What interventions are being tested in trial NCT05538663?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), Bacillus Calmette Guerin (DRUG).

Who is sponsoring clinical trial NCT05538663?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05538663 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.