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Study on Mitomycin and BCG for Patients with Recurrent Non-Muscle Invasive Bladder Cancer

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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 recurrent non-muscle invasive bladder cancer. This form of cancer affects the bladder but does not invade the muscle layer. The study will explore two treatment options. The first treatment involves a medication called Mitomycin, which is used in a process called chemoablation. Chemoablation is a method where the medication is directly applied to the bladder to destroy cancer cells. The second treatment option is a standard procedure called transurethral resection of bladder tumor (TURBT), followed by additional therapy using another medication called BCG (Bacillus Calmette-Guérin), which is a type of bacteria used to stimulate the immune system to fight cancer cells.

The purpose of this study is to determine if the chemoablation treatment with Mitomycin is more effective in the long term compared to the standard TURBT procedure with BCG therapy. Participants in the study will be randomly assigned to receive either the Mitomycin treatment or the TURBT procedure with BCG. The study will monitor the participants over a period of time to see how well each treatment works in preventing the cancer from coming back.

Throughout the study, participants will receive regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on which treatment option offers better outcomes for patients with recurrent non-muscle invasive bladder cancer. This research could help improve future treatment strategies for this type of cancer.

The research process

The trial runs in 7 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will need to provide informed consent, indicating that you understand the information and agree to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking for tumour recurrence after a previous low-grade bladder tumour, ensuring the tumour is smaller than 2 cm, and confirming you are at least 18 years old.
Step 3
Treatment allocation
You will be randomly assigned to one of two treatment groups. One group will receive chemoablation with mitomycin, and the other will undergo a procedure called TURBT (transurethral resection of bladder tumour) followed by additional therapy.
Step 4
Chemoablation treatment
If you are in the chemoablation group, you will receive mitomycin through a process called intravesical use, where the medication is placed directly into the bladder. The dosage is 40 mg, and the treatment schedule will be explained to you by the medical team.
Step 5
TURBT and adjuvant therapy
If you are in the TURBT group, you will undergo a surgical procedure to remove the tumour, followed by additional therapy with BCG (Bacillus Calmette-Guérin) bacteria, also administered intravesically.
Step 6
Follow-up visits
Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. These visits will include medical examinations and tests as needed.
Step 7
Long-term monitoring
Your progress will be monitored for up to five years to assess the long-term effects of the treatment. This includes checking for any recurrence of the tumour and evaluating overall health outcomes.

Who can join the trial?

5 criteria

**Tumor recurrence**: You have had a return of a previous **urothelial tumor** (a type of bladder cancer) that was **Ta low-grade** (a non-aggressive form).
**Tumors smaller than 2 cm**: The size of your tumors should be less than 2 centimeters in diameter.
**Negative urine cytology (optional)**: A test of your urine does not show cancer cells. This is optional.
**18 years of age or older**: You must be at least 18 years old.
**Ability to understand and comprehend**: You should be able to understand the information given to you, both written and spoken.

Who cannot join the trial?

8 criteria

Patients with **muscle-invasive bladder cancer** cannot participate. This means the cancer has spread into the muscle layer of the bladder.
Patients with **other types of cancer** that are not bladder cancer are excluded.
Patients who have had a **major surgery** within the last 4 weeks are not eligible. Major surgery refers to any significant surgical procedure that requires a longer recovery time.
Patients with **severe heart problems** cannot take part. This includes conditions like heart failure or recent heart attacks.
Patients with **severe kidney problems** are excluded. This means the kidneys are not working well enough to filter waste from the blood.
Patients who are **pregnant or breastfeeding** cannot participate.
Patients who are **unable to follow the study procedures** for any reason, such as language barriers or cognitive impairments, are not eligible.
Patients who are currently participating in another **clinical trial** are excluded. A clinical trial is a research study to test new treatments.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aalborg University Hospital
Aalborg, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark
Responsive
Sykehuset I Vestfold HF
Tonsberg, Norway

Trial locations

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Investigated drugs

Mitomycin C (MMC)
is a type of chemotherapy drug used in this trial. It works by stopping cancer cells from growing and multiplying. In this study, it is used in a method called chemoablation, which means the drug is applied directly to the bladder to destroy cancer cells. The goal is to see if this approach is more effective in the long term compared to other treatments.
Transurethral Resection of Bladder Tumor (TURBT)
is a surgical procedure used to remove bladder tumors. In this trial, it is part of the standard treatment for patients with recurrent bladder cancer. After the surgery, additional therapy is given to help prevent the cancer from coming back.
Intravesical Instillation Therapy
involves placing a liquid medication directly into the bladder through a catheter. This therapy is used after the surgical removal of bladder tumors to help prevent the cancer from returning. It is part of the standard treatment being compared in this study.

Mitomycin

What is already known about the treatment

Mitomycin C (MMC) – Mitomycin C is administered directly into the bladder through a catheter, a method known as intravesical therapy. It is currently being studied for its effectiveness in treating recurrent non-muscle invasive bladder cancer, with a focus on whether it works better than standard surgical removal of tumors followed by chemotherapy. The main use of Mitomycin C is to treat bladder cancer by preventing cancer cells from growing and spreading. It works at the molecular level by interfering with the DNA of cancer cells, stopping them from multiplying. Mitomycin C is classified as an antineoplastic antibiotic, which means it is a type of chemotherapy drug that comes from natural sources and is used to treat cancer.

Investigated diseases

Recurrent 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 invaded the muscle layer. It is known for its tendency to return after initial treatment, which is why it is termed "recurrent." The disease typically presents as small, superficial tumors that can be removed but often reappear. Over time, these tumors may increase in number and size, leading to more frequent recurrences. The progression of the disease can vary, with some cases remaining superficial while others may eventually invade deeper layers of the bladder. Monitoring and management are crucial to control the recurrence and prevent further progression.