Actively Recruiting
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
Led by Case Comprehensive Cancer Center · Updated on 2026-05-07
40
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0
- Unifocal or limited multifocal disease suitable for complete removal by partial cystectomy
- Age over 18 years
- Karnofsky Performance Status 70 or higher, or ECOG performance status 0 or 1
- Normal organ and marrow function including bilirubin, AST, ALT, neutrophil count, platelet count, and hemoglobin
- Ability and willingness to provide informed consent
- Tumor size less than or equal to 5 cm by imaging
- No prior treatment for muscle-invasive bladder cancer
You will not qualify if you...
- Presence of hydronephrosis
- Multifocal disease not suitable for removal by partial cystectomy
- Presence of distant carcinoma in situ
- Clinical lymph node (N+) or distant metastasis (M+) disease
- Clinical stage T4 or higher disease
- Non-urothelial bladder cancer types
- Concurrent urothelial cancer in the upper urinary tract or urethra
- Not a surgical candidate due to other medical conditions or refusal of surgery
- Any condition that would compromise participant safety or interfere with study assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
N
Nima Almassi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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