A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

Brief description of study

This is a study that looks at whether it's safe to treat patients with bladder cancer who have certain gene changes (called DDR gene alterations) in their tumor. These patients have had a procedure called TURBT (a way to remove part of the tumor) before treatment. They will get chemotherapy with gemcitabine and cisplatin. The study will check if the treatment works well by looking at how many patients are still cancer-free three years after they start treatment. If more than 80% of the patients are cancer-free at that time, the treatment will be considered safe. The patients will also be watched for five years to see how many stay cancer-free. If patients' tumors do not have these gene changes, or if the tumor shrinks but not enough, they will have their bladder removed (called cystectomy) and will be followed for five years to see if the cancer comes back or if they survive longer. If patients who could have had bladder-preserving treatment end up having their bladder removed, they will also be watched for five years to see how they do.


Clinical Study Identifier: s23-01043
ClinicalTrials.gov Identifier: NCT03609216
Principal Investigator: Katie S. Murray.
Other Investigators: Victor Ricardo Adorno Febles, Minas Platon Economides, James S Wysock, Samir Taneja, Scot Niglio, William C Huang, Hank Ng, David R. Wise.


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