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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 ECOG Performance Status 0-2.
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 belowSelect...
I am older than 18 years.
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I am able to care for myself and perform daily activities.
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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 visible bladder tumors have been surgically removed before joining this study.
BRIDGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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 moreBRIDGE 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
150,725 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,052 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,930,880 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am older than 18 years.You cannot have had a serious allergic reaction to docetaxel or drugs containing polysorbate 80 in the past.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am able to care for myself and perform daily activities.I have another cancer type, but it won't affect this trial's treatment.I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.I had non-invasive bladder cancer, treated and confirmed clear on follow-up tests.My hepatitis B virus is under control with treatment.My bladder cancer is confirmed high-grade but not muscle invasive.I haven't had bladder treatments, except for chemo during bladder tumor surgery.I had a follow-up bladder tumor surgery within the last 3 months.My blood tests show normal organ function and I meet the required levels for white blood cells, neutrophils, and platelets.I have used gemcitabine or docetaxel for cancer, but not for bladder cancer.I am not planning to have children and will use or am using effective birth control.My visible bladder tumors have been surgically removed before joining this study.I have never had advanced or spreading bladder cancer.I am HIV positive, on treatment, and my viral load is undetectable.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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