Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT06290687

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

Conditions: Malignant Neoplasm of Bladder, Muscle Invasive Bladder Carcinoma

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Case Comprehensive Cancer Center

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

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06290687). StuddyBuddy aggregates publicly available trial information.