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Gemcitabine + Docetaxel vs BCG for Bladder Cancer (BRIDGE Trial)
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.
BRIDGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRIDGE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BRIDGE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm B
- Group 2: Arm A
- 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.
- 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
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."
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."
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."
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