Your session is about to expire
← Back to Search
Anti-metabolites
Gemcitabine vs Water Irrigation for Urothelial Cancer
Phase 3
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy proven UTUC with plan for excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent
Age 18 - 90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is comparing recurrence rates of bladder cancer using two different methods: intravesical gemcitabine and continuous bladder irrigation with sterile water.
Who is the study for?
This trial is for adults aged 18-90 with biopsy-proven upper tract urothelial carcinoma (UTUC) who are planning surgery to remove the cancer. Participants must be able to have children and agree to use birth control during the study. They should expect to live more than a year and not have had bladder cancer or bilateral UTUC within the last three years.Check my eligibility
What is being tested?
The study compares two methods of preventing bladder cancer recurrence after UTUC surgery: one uses gemcitabine, a chemotherapy drug, in the bladder; the other uses sterile water irrigation. The goal is to see which method is better at stopping cancer from coming back.See study design
What are the potential side effects?
Gemcitabine can cause side effects like nausea, low blood counts, fever, rash or allergic reactions. Sterile water irrigation may lead to discomfort or urinary symptoms but generally has fewer risks compared to chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed UTUC diagnosis and am scheduled for surgery to remove it.
Select...
I am between 18 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
intravesical recurrence
Secondary outcome measures
treatment-related associated adverse event rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: sterile water irrigationExperimental Treatment1 Intervention
intravesical continuous bladder irrigation with sterile water for 1 - 3 hours and a total instilled volume of approximately 4 - 16 liters
Group II: gemcitabineActive Control1 Intervention
intravesical instillation of gemcitabine (1 g in 50 mL saline) with dwell time of 1 - 3 hours
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,643 Total Patients Enrolled
1 Trials studying Urothelial Cancer
2 Patients Enrolled for Urothelial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer in both upper urinary tracts or had it in one with no signs for over 3 years.I agree to use birth control or abstain from sex during and for 90 days after the study.I am scheduled for complete bladder removal surgery.I have a confirmed UTUC diagnosis and am scheduled for surgery to remove it.I had bladder cancer less than 3 years ago and am now cancer-free.I am between 18 and 90 years old.You are expected to live for at least one more year.
Research Study Groups:
This trial has the following groups:- Group 1: gemcitabine
- Group 2: sterile water irrigation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared sterile water for use in medical procedures?
"Sterile water irrigation has been proven safe in multiple clinical trials, so it receives a score of 3."
Answered by AI
Are individuals who are middle-aged being allowed to participate in this experiment?
"According to the inclusion criteria laid out by the researchers, potential participants for this trial must be aged 18 to 90. However, there are 106 other studies available for people under 18 and 3008 for patients over 65."
Answered by AI
When would a doctor recommend using sterile water irrigation?
"Small cell lung cancer (sclc) can be treated through the use of sterile water irrigation. This method is also useful for treating head and neck carcinoma, locally advanced pancreatic adenocarcinoma, and cervical cancers."
Answered by AI
What other medical research exists on the effects of sterile water irrigation?
"There are 463 active studies and 136 trials in Phase 3 for sterile water irrigation. Though there are several studies for sterile water irrigation based in Woolloongabba, Queensland, there are 24302 locations running studies for sterile water irrigation."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger