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Vaccine

Gemcitabine + Docetaxel vs BCG for Bladder Cancer (BRIDGE Trial)

Phase 3
Recruiting
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be > 18 years of age.
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

BRIDGE Trial Summary

This trial tests if a new treatment, Gemcitabine + Docetaxel, is better or worse than the usual BCG therapy for bladder cancer. Primary goal is to measure event free survival, secondary objectives include changes in cancer-specific QOL, cystectomy free survival, progression free survival, and safety/toxicity.

Who is the study for?
This trial is for adults over 18 with high-grade non-muscle invasive bladder cancer who haven't had previous intravesical therapy, except perioperative chemo at TURBT time. They must have good performance status (able to carry out daily activities), no severe heart disease, and adequate organ function. Pregnant or breastfeeding individuals are excluded, as well as those with a history of muscle-invasive or advanced urothelial carcinoma.Check my eligibility
What is being tested?
The study compares the effectiveness of Gemcitabine + Docetaxel (GEMDOCE) versus Bacillus Calmette-Guerin (BCG) in treating patients new to BCG treatment for bladder cancer. It measures how long patients remain free from cancer events after these treatments and assesses quality of life, cystectomy-free survival, progression-free survival, safety, and toxicity.See study design
What are the potential side effects?
Potential side effects include allergic reactions to docetaxel or drugs containing polysorbate 80. Both GEMDOCE and BCG can cause immune system impacts leading to infection risks; GEMDOCE may also affect blood cell counts and liver function.

BRIDGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I can understand and am willing to sign the consent form, or I have someone who can do it for me.
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I am able to care for myself and perform daily activities.
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I have another cancer type, but it won't affect this trial's treatment.
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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
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My hepatitis B virus is under control with treatment.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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My bladder cancer is confirmed high-grade but not muscle invasive.
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I haven't had bladder treatments, except for chemo during bladder tumor surgery.
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I had a follow-up bladder tumor surgery within the last 3 months.
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My blood tests show normal organ function and I meet the required levels for white blood cells, neutrophils, and platelets.
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I have used gemcitabine or docetaxel for cancer, but not for bladder cancer.
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My visible bladder tumors have been surgically removed before joining this study.
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I am HIV positive, on treatment, and my viral load is undetectable.

BRIDGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival
Secondary outcome measures
Cystectomy free survival
Progression Free Survival
Quality of Life EORTC NMIBC-24
+1 more

BRIDGE Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
BCG
Group II: Arm AExperimental Treatment2 Interventions
Gemcitabine + Docetaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
149,960 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,052 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,471 Total Patients Enrolled

Media Library

Bacillus Calmette Guerin (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05538663 — Phase 3
Bladder Cancer Research Study Groups: Arm B, Arm A
Bladder Cancer Clinical Trial 2023: Bacillus Calmette Guerin Highlights & Side Effects. Trial Name: NCT05538663 — Phase 3
Bacillus Calmette Guerin (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538663 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this investigation?

"Current records on clinicaltrials.gov declare that this scientific investigation is actively gathering subject enrolment, having first been posted in December 1st 2022 and last modified January 12th 2023."

Answered by AI

What is the current participation rate of this medical experiment?

"Affirmative. Clinicaltrials.gov has the most up-to-date information and confirms that participant recruitment for this medical study is ongoing, having first been posted on December 1st 2022 before being edited on January 12th 2023. The trial requires 870 patients to be enrolled at a single location."

Answered by AI

What consequences can patients anticipate from receiving the treatments in Arm B?

"Our enterprise has appraised Arm B with a score of 3, denoting that there is existing evidence to suggest its efficacy and multiple layers of security."

Answered by AI
~580 spots leftby Nov 2029