40
Participants
Start Date
February 18, 2025
Primary Completion Date
January 29, 2026
Study Completion Date
January 29, 2027
Neoadjuvant Chemotherapy
"Standard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include:~* Cisplatin - Gemcitabine (Gem/Cis)~* Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)"
Partial cystectomy with Extended pelvic lymph node dissection
Partial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.
Adjuvant systemic therapy
Standard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.
RECRUITING
Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland
Case Comprehensive Cancer Center
OTHER