The goal of this study is to evaluate a treatment called trimodal therapy after a course of neoadjuvant therapy (treatment given as a first step to shrink a tumor before main treatment) as a way to preserve the bladder in people with muscle invasive bladder cancer (MIBC) with variant histology (when the tumor shows microscopic variations that differ from the typical cancer type). Trimodal therapy is a type of bladder preservation treatment that combines radiation therapy and chemotherapy; it has been used successfully in bladder cancer that arises from traditional urothelial cells (cells that are in the bladder). This study is investigating the use of neoadjuvant chemotherapy followed by trimodal therapy in patients whose tumors have cells that are not just urothelial in origin. Researchers also want to learn whether a biomarker test is helpful in identifying relapse or recurrence of disease after treatment. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease; it can used to predict someone’s response to a specific treatment. The U.S. Food and Drug Administration (FDA) has approved this drug as it is being used in this study.
What is the full name of this clinical trial?
IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients with Muscle Invasive Bladder Cancer with Variant Histology