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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Enrolling; Phase 2

Conditions: Malignant Neoplasm of Bladder; Muscle Invasive Bladder Carcinoma

Treatments: Procedure: Partial cystectomy with Extended pelvic lymph node dissection; Drug: Neoadjuvant Chemotherapy; Drug: Adjuvant systemic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06290687

CASE5824

Details and patient eligibility

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.

Full description

Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

• Subjects must have normal organ and marrow function as defined below:

  • Total bilirubin within normal limits

  • AST (SGOT) ≤ 2.5 X institutional upper limit of normal

  • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal

  • Bone marrow:

    • Absolute neutrophil count (ANC) ≥ 1,500/mm3
    • Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

• Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.

• Treatment naive for MIBC.

Exclusion criteria

• 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.
• Presence of cT4+ disease.
• Non-urothelial histology.
• Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
• Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cisplatin Eligible Participants

Experimental group

Description:

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

Treatment:

Drug: Adjuvant systemic therapy

Drug: Neoadjuvant Chemotherapy

Procedure: Partial cystectomy with Extended pelvic lymph node dissection

Cisplatin Ineligible Participants

Experimental group

Description:

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

Treatment:

Drug: Adjuvant systemic therapy

Procedure: Partial cystectomy with Extended pelvic lymph node dissection