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

Conditions

• Malignant Neoplasm of Bladder
• Muscle Invasive Bladder Carcinoma

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Neoadjuvant Chemotherapy — DRUG
  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 — PROCEDURE
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Dec 29, 2026

Completion

Dec 29, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cisplatin Eligible Participants
  Participants who are deemed eligible for cisplatin-based NAC will undergo: * Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants) * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible patients
• Experimental: Cisplatin Ineligible Participants
  Participants who are deemed ineligible for cisplatin-based NAC will undergo: * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible participants

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: Up to 24 months from date of post-surgery baseline scan ]

Central Contacts

• Nima Almassi, MD
  (216) 444-1825
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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