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

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

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.

Conditions3

Locations1 site

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