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

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 198-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (339% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer (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
ECOG-ACRIN Cancer Research Group

75 total trials

What the registry record for NCT05538663 still lists

NCT05538663 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, above the 198-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (339% higher).

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 names 20 study sites across 5 states, led by 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.

Learn More About Clinical Trials

Similar trials for Non-muscle Invasive Bladder Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05538663's enrollment target sits among peer trials

870 2nd of 30 the highest of 30 other Non-muscle Invasive Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05538663, the US trial registry maintained by the National Library of Medicine. NCT05538663 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.