Bladder Cancer S1806

Title: Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Brief Summary: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Eligibility Criteria:

• Clinical  T2-T4a N0M0 with primary urothelial carcinoma (mixed histology allowed but small cell carcinoma excluded).
• Patients must undergo a pelvic exam under anesthesia (with the findings and clinical stage recorded in the operative report) and TURBT within 70 days prior to randomization. The exam helps in excluding patient who are T4b.
• Patients with unilateral hydronephrosis are eligible if their kidney function permits enrollment on the study.
• No Diffuse CIS.
• No UC at any site outside of the urinary bladder within the previous 2 years except Ta/T1/ (CIS) of the upper urinary tract if the patient had undergone complete nephrouretrectomy.
• No prior pelvic radiation

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital