Study on Partial Bladder Removal and Lymph Node Surgery with Standard Treatment for Muscle-Invasive Bladder Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06290687

Provider View

This clinical trial is exploring whether removing part of the bladder, along with nearby lymph nodes, can effectively treat muscle-invasive bladder cancer. The study will also look at the safety of this approach and how it affects patients' quality of life compared to removing the entire bladder.

Patient Parameters

Program Overview

The aim of this study is to find out if a partial bladder removal, along with extended removal of pelvic lymph nodes, can be a safe and effective treatment for muscle-invasive bladder cancer. This approach is being compared to the standard treatment of removing the entire bladder. Participants will first receive standard pre-surgery treatment for about 4 to 6 weeks. After this, they will undergo surgery to remove part of the bladder and nearby lymph nodes. Following surgery, participants will receive additional systemic therapy to help prevent cancer from returning.

Description

The standard treatment for muscle-invasive bladder cancer usually involves removing the entire bladder, along with nearby lymph nodes, and providing chemotherapy before surgery. While this method is effective, it can lead to complications and affect quality of life. This study is testing a less invasive option, where only part of the bladder is removed, which may result in fewer complications and better quality of life. This approach is already included in treatment guidelines for certain bladder cancer patients. However, there is limited information on how well this treatment works, especially regarding patients' quality of life. This trial will evaluate the safety and effectiveness of partial bladder removal with extended lymph node surgery, along with standard systemic therapy, in eligible patients.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of bladder cancer, specifically urothelial carcinoma, at clinical stage T2-3N0M0.
  • Can include certain types of bladder cancer like micropapillary, glandular, squamous, and sarcomatoid variants.
  • Cancer must be limited to one area or a few areas that can be completely removed with partial bladder surgery, as determined by the treating doctor.
  • Must be over 18 years old.
  • Must be in good general health, with a performance status score of 70 or higher on the Karnofsky scale, or 0 or 1 on the ECOG scale.
  • Must have normal organ and bone marrow function, including:
    • Normal bilirubin levels
    • AST and ALT levels no more than 2.5 times the normal limit
    • Adequate blood cell counts, including neutrophils, platelets, and hemoglobin
  • Must be able to understand and sign a consent form.
  • Tumor must be 5 cm or smaller in size, as seen on scans.
  • Must not have received prior treatment for muscle-invasive bladder cancer.

Exclusion Criteria

  • Have a condition called hydronephrosis.
  • Have multiple cancer areas that cannot be completely removed with partial bladder surgery.
  • Have cancer that has spread to distant areas.
  • Have cancer that has spread to lymph nodes or other organs.
  • Have a more advanced stage of cancer (cT4+).
  • Have a type of bladder cancer that is not urothelial.
  • Have cancer in the upper urinary tract or urethra.
  • Are not suitable for surgery due to other health issues or refuse surgery.
  • Have any condition that the study doctor believes would not be in the patient's best interest to participate in the study.

Locations

FACILITYZIPCITYSTATE
Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center44195ClevelandOhio

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