Full Title
A Randomized Phase III Trial of Intravesical BCG VeRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) (EA8212) (CIRB)Purpose
Researchers in this study are comparing two treatments for bladder cancer that has not invaded the muscle wall (non-muscle invasive bladder cancer). The usual treatment is intravesical BCG (administration of Bacillus Calmette Guerin directly into the bladder), a bacterium that has been used for decades against bladder cancer. It will be compared to treatment with two chemotherapy drugs (docetaxel and gemcitabine) given directly into the bladder.
Participants will be randomly assigned to BCG or chemotherapy, and researchers will compare the rate of cancer recurrence between the two groups. The researchers are also interested in learning whether people who receive chemotherapy directly into the bladder have better quality of life than those who have treatment with BCG.
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have non-muscle invasive bladder cancer and must have had the tumor removed before receiving the study treatment.
- Prior intravesical BCG treatment is not permitted.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Eugene Pietzak at 646-422-4781.