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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCase Comprehensive Cancer Center

About this trial

The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

Eligibility criteria

Qualifiers

Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.

Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.

Age >18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study.

Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.

Disqualifiers

Presence of hydronephrosis.

Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.

Presence of distant carcinoma in situ.

Presence of clinical N+ or M+ disease.

Trial design

Treatments tested in this trial

  • Neoadjuvant Chemotherapy
  • Partial cystectomy with Extended pelvic lymph node dissection
  • Adjuvant systemic therapy

Treatment groups

40 Participants
are divided into 2 treatment groups