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Study Comparing Gemcitabine and Mitomycin for Patients with Intermediate Risk Non-Muscle Invasive Bladder Cancer

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 bladder cancer known as non-muscle invasive bladder cancer (NMIBC), which has an intermediate risk of coming back after surgery. The study is comparing two treatments: Gemcitabine and Mitomycin. Gemcitabine is given as a solution for infusion, which means it is administered directly into the bladder, while Mitomycin is also given directly into the bladder as an intravesical solution. The purpose of the study is to see if Gemcitabine can help prevent the cancer from returning better than Mitomycin.

Participants in the study will receive one of the two treatments after their initial surgery to remove the bladder tumor. The study will last for a period of up to six months, during which the effects of the treatments will be monitored. The main focus is on how long patients remain free from cancer recurrence. Additionally, the study will look at other factors such as any side effects experienced, the overall health and quality of life of the participants, and the economic impact of the treatments.

This trial aims to provide valuable information on the effectiveness of these treatments in preventing the return of bladder cancer, potentially leading to improved treatment options for patients with intermediate-risk NMIBC. The study will help determine which treatment offers better outcomes in terms of keeping the cancer from coming back and maintaining the quality of life for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed for individuals with primary or recurrent non-muscle invasive bladder cancer, classified as having an intermediate risk of recurrence.
Step 2
Treatment with mitomycin
The first treatment involves the use of mitomycin, administered as an intravesical solution. This means the medication is delivered directly into the bladder.
The dosage for mitomycin is 40 mg. The frequency and duration of administration are determined by the study protocol and will be communicated during the trial.
Step 3
Treatment with gemcitabine
The second treatment involves the use of gemcitabine, provided as a solution for infusion. This medication is also administered directly into the bladder.
The concentration of gemcitabine is 100 mg/ml. The specific schedule for administration will be outlined as per the study guidelines.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess recurrence-free survival, which is the primary goal of the study.
Secondary assessments include evaluating local side effects, quality of life two weeks after the last treatment, progression-free survival, health economics, and any adverse events.
Step 5
Completion of the trial
The trial is expected to conclude by January 1, 2026. Participants will be informed of the outcomes and any further steps required after the study ends.

Who can join the trial?

5 criteria

The patient must have **primary** or **recurrent** non-muscle invasive bladder cancer. This means the cancer is in the bladder but hasn't spread into the muscle layer.
The cancer should have an **intermediate risk of recurrence**, which means there's a moderate chance it could come back after treatment.
Both **men and women** can participate in the study.
The study includes people from certain age groups, but the specific ages are not listed here.
The study may include people who are considered part of a **vulnerable population**, which means they might need extra protection or care.

Who cannot join the trial?

10 criteria

Patients with **muscle-invasive bladder cancer** cannot participate. This means the cancer has spread into the muscle layer of the bladder.
Patients who have had a **different type of cancer** in the past, unless it was treated and has not come back for at least 5 years, are excluded.
Patients with **severe kidney problems** are not eligible. This refers to kidneys not working well enough to filter waste from the blood.
Patients with **severe liver problems** cannot join. This means the liver is not functioning properly to process substances in the body.
Patients who are **pregnant or breastfeeding** are not allowed to participate.
Patients who have had an **allergic reaction** to similar medications in the past are excluded. An allergic reaction is when the body reacts badly to a substance.
Patients who are currently participating in another **clinical trial** are not eligible. A clinical trial is a research study to test new treatments.
Patients with **serious heart conditions** are excluded. This refers to problems with the heart that could affect health.
Patients who have had a **major surgery** within the last 4 weeks cannot participate. Major surgery is a significant operation that requires recovery time.
Patients with **uncontrolled infections** are not eligible. This means infections that are not being managed or treated effectively.

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Verified sites

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Region Joenkoepings Laen
Verified
Jönköping, Sweden
Region Skane Skanes Universitetssjukhus
Verified
Lund, Sweden

Trial locations

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Investigated drugs

Gemcitabine
is a medication used in this trial to see if it can help prevent the return of bladder cancer after initial treatment. It is being tested to find out if it is more effective than another medication in keeping the cancer from coming back.
Mitomycin
is another medication used in this trial. It is being compared to gemcitabine to determine which one is better at preventing the recurrence of bladder cancer after the initial treatment.

What is already known about the treatment

Gemcitabine
This medication is administered through instillation directly into the bladder. It is currently being studied for its effectiveness in preventing the recurrence of non-muscle invasive bladder cancer after tumor removal. Gemcitabine works by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and multiplication. It is classified as an antimetabolite chemotherapy drug.
Mitomycin
This medication is also administered via bladder instillation. It is used in the treatment of non-muscle invasive bladder cancer to reduce the risk of cancer recurrence. Mitomycin acts by cross-linking DNA strands, which prevents cancer cells from dividing and growing. It belongs to the class of antibiotics with antitumor activity.

Investigated diseases

Non-muscle invasive bladder cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not spread into the muscle layer. It is often detected at an early stage and is known for its potential to recur after treatment. The disease is classified as intermediate risk when there is a moderate chance of recurrence following surgical removal of the tumor. Progression of the disease can lead to more invasive forms if not monitored and managed properly. Regular follow-ups are essential to detect any recurrence or progression.