Study Comparing Gemcitabine and Water Irrigation for Upper Tract Urothelial Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04865939

This clinical trial is exploring whether using sterile water to rinse the bladder during surgery is as effective as using the drug gemcitabine to prevent bladder cancer from returning after surgery for upper tract urothelial carcinoma.

Patient Parameters

Program Overview

The study aims to find out if rinsing the bladder with sterile water during surgery can prevent bladder cancer from coming back as effectively as using the drug gemcitabine. Upper tract urothelial carcinoma is a rare type of cancer that can often return in the bladder after surgery. Currently, some doctors use gemcitabine during surgery to help prevent this, but it can be difficult to use in some hospitals. This study will compare the effectiveness of gemcitabine and sterile water in preventing cancer recurrence.

Description

Upper tract urothelial carcinoma is a rare cancer that affects the urinary system. After surgery to remove the cancer, it can often return in the bladder. This study is testing two methods to prevent this: using the drug gemcitabine or rinsing the bladder with sterile water during surgery.

Gemcitabine is a drug that is sometimes used during surgery to help prevent cancer from coming back, but it can be hard to use in some hospitals. Rinsing the bladder with sterile water is a simpler method that might work just as well.

The study will compare how often cancer returns in patients who receive gemcitabine versus those who receive sterile water. If both methods are equally effective, using water could be a better option because it is easier to use and has fewer risks for patients and medical staff.

The study will involve patients who are having surgery to remove upper tract urothelial carcinoma. Participants will be randomly assigned to receive either gemcitabine or sterile water during their surgery. Researchers will then track how often cancer returns in each group.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with upper tract urothelial carcinoma and scheduled for surgery to remove it.
  • Aged between 18 and 90 years.
  • Expected to live for more than one year.
  • Women who can become pregnant and men must agree to use birth control during the study and for 90 days after treatment.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Have had bladder cancer within the last three years.
  • Have cancer in both upper tracts at the same time, unless the other side was treated more than three years ago.
  • Planning to have the bladder completely removed.
  • Have a very small bladder capacity, as judged by the doctor.
  • Have allergies to gemcitabine or similar drugs.

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