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Study Comparing Chemotherapy Before or After Surgery for Patients with Upper Tract Urothelial Carcinoma Using Gemcitabine

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Upper Tract Urothelial Carcinoma, which affects the upper part of the urinary system. The study is comparing two different approaches to chemotherapy treatment: one given before surgery, known as neo-adjuvant chemotherapy, and one given after surgery, known as adjuvant chemotherapy. The chemotherapy treatment being used in this study includes a drug called Gemcitabine, which is administered as a powder mixed into a solution for infusion. The purpose of the study is to determine how well patients with this type of cancer can tolerate and complete the planned chemotherapy courses.

Participants in the study will be randomly assigned to receive either neo-adjuvant or adjuvant chemotherapy. The study will monitor how many patients are able to start and complete three courses of the planned chemotherapy. It will also look at the doses of chemotherapy that patients receive compared to what was planned. The study aims to gather information on the effectiveness and feasibility of these treatment approaches for patients with Upper Tract Urothelial Carcinoma.

Throughout the study, researchers will also track the survival rates of participants, including how long they remain free of cancer and their overall survival. This information will help in understanding the potential benefits and challenges of using chemotherapy before or after surgery for this type of cancer. The study is expected to continue until the end of 2025, providing valuable insights into the treatment of Upper Tract Urothelial Carcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the details of the study.

    You must be at least 18 years old and have a confirmed diagnosis of upper tract urothelial carcinoma (UTUC).

  2. Step 2

    Initial assessments

    You will undergo various tests to confirm your eligibility. These include a CT scan of the chest, abdomen, and pelvis, and a bone scan to ensure there is no evidence of cancer spread.

    Women of childbearing potential will need to take a pregnancy test and agree to use effective contraception during the study.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either neo-adjuvant chemotherapy (before surgery) or adjuvant chemotherapy (after surgery).

    This process is random to ensure fairness and scientific accuracy.

  4. Step 4

    Chemotherapy treatment

    You will receive chemotherapy with a drug called gemcitabine through an infusion. This means the medication will be given directly into your bloodstream.

    The treatment plan includes three courses of chemotherapy. The exact dosage and frequency will be determined by your healthcare team based on your specific needs.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, your health and response to treatment will be closely monitored. This includes regular check-ups and tests to assess your condition.

    The study aims to evaluate the effectiveness of the treatment and your ability to complete the planned chemotherapy courses.

  6. Step 6

    Completion of the study

    After completing the treatment, you will continue to be monitored for 1- and 2-year disease-free survival, overall survival, and cancer-specific survival.

    This follow-up period is crucial to understand the long-term effects and benefits of the treatment.

Who can join the trial?

8 criteria

  • Provide written informed consent, which means you agree to participate in the study after being informed about all aspects of it.
  • Be 18 years or older.
  • Have a diagnosis of Upper Tract Urothelial Carcinoma (UTUC), confirmed by medical tests.
  • Have UTUC classified as cT2-cT4 cN0-N1 M0 according to the TNM classification, which is a system used to describe the size and spread of cancer.
  • If you are a woman who can have children, you must have a negative pregnancy test and agree to use effective birth control.
  • Do not have bladder cancer, or if you do, it must be non-muscle invasive bladder cancer, meaning it has not spread into the muscle layer of the bladder.
  • Have adequate organ function, as shown by blood test results.
  • Have a CT scan of the chest, abdomen, and pelvis, and a bone scan that shows no evidence of cancer spreading to other parts of the body.

Who cannot join the trial?

10 criteria

  • Patients with **severe kidney problems** cannot participate. This means if your kidneys are not working well enough, you may not be eligible.
  • If you have had another type of **cancer** in the past, you might not be able to join, unless it was a type that is not expected to come back.
  • Patients who are **pregnant or breastfeeding** are not allowed to participate.
  • If you have a **serious infection** that is not controlled, you cannot take part in the study.
  • Patients who have had a **major surgery** recently may not be eligible.
  • If you have a **heart condition** that is not stable, you might not be able to join the study.
  • Patients who are taking certain **medications** that could interfere with the study treatment may not be eligible.
  • If you have a **history of allergic reactions** to similar treatments, you cannot participate.
  • Patients with **mental health conditions** that could affect their ability to follow the study procedures may not be eligible.
  • If you are participating in another **clinical trial**, you might not be able to join this one.
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Investigated drugs

Cisplatin is a type of chemotherapy medication used to treat various types of cancer, including urothelial carcinoma, which affects the urinary system. In this clinical trial, cisplatin is being used to see how well it works when given before surgery (neo-adjuvant) or after surgery (adjuvant) to help eliminate cancer cells. The goal is to determine if patients can handle the treatment and complete the planned courses of chemotherapy.

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently used in medicine as a chemotherapy drug, particularly for treating various types of cancer, including upper tract urothelial carcinoma, which affects the urinary system. The main therapeutic use of cisplatin is to kill cancer cells and shrink tumors. At the molecular level, cisplatin works by binding to the DNA in cancer cells, which prevents them from dividing and growing. It is classified as a platinum-based chemotherapy agent.

Investigated diseases

Upper Tract Urothelial Carcinoma – This disease affects the lining of the upper urinary tract, which includes the renal pelvis and ureters. It is characterized by the abnormal growth of cells in these areas, which can form tumors. The disease progresses as these tumors grow and potentially spread to other parts of the urinary system or nearby tissues. As the carcinoma advances, it may cause symptoms such as blood in the urine, pain in the back or side, and frequent urination. The progression can lead to obstruction of the urinary tract, affecting kidney function. The disease is considered rare and requires careful monitoring to understand its development.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514991-41-01Protocol code2016-004017-27Estimated enrolment201 patientsSponsorEuropean Uro-Oncology Group Stichting

sourced from the EU Clinical Trials Register and site verification

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