Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 18, 2025

Primary Completion Date

January 29, 2026

Study Completion Date

January 29, 2027

Conditions
Malignant Neoplasm of BladderMuscle Invasive Bladder Carcinoma
Interventions
DRUG

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)"

PROCEDURE

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.

DRUG

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.

Trial Locations (1)

44195

RECRUITING

Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER