Recruiting

Study of Mitomycin-C with Electromotive Drug Administration before Surgery in Patients with 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 focuses on non-muscle invasive bladder cancer, a type of cancer that affects the inner lining of the bladder without spreading to the muscle layer. The study examines a treatment approach using mitomycin C, a medication that helps prevent cancer cells from growing and spreading. The medication will be administered in two different ways: through a special technique called electromotive drug administration (EMDA) before surgery, or through standard delivery after surgery.

The purpose of this research is to determine if giving mitomycin C using the EMDA method before a surgical procedure called transurethral resection (a surgery to remove abnormal tissue from the bladder) works better than the traditional method of giving the medication after surgery. The study will compare how long patients remain free from cancer return between these two different approaches.

During the study, patients will be randomly assigned to receive either the new EMDA treatment before surgery or the standard treatment after surgery. The medication will be delivered directly into the bladder through a thin tube. Patients will be monitored over time to check if their cancer returns or gets worse. The study will also look at how well patients tolerate the treatment and any side effects that may occur.

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
Initial medical procedure
You will be assigned randomly to one of two treatment groups for your bladder tumor treatment.
Both groups will receive mitomycin C, a medication used to treat bladder cancer, but through different methods.
Step 2
Treatment administration - Group 1
If assigned to the first group, you will receive mitomycin C through electromotive drug administration (EMDA) before the surgical procedure.
EMDA is a method that uses a mild electrical current to help the medication penetrate the bladder wall more effectively.
Step 3
Treatment administration - Group 2
If assigned to the second group, you will receive mitomycin C through standard passive diffusion after the surgical procedure.
This involves placing the medication directly into the bladder through a catheter.
Step 4
Surgical procedure
All patients will undergo a transurethral resection (TUR).
TUR is a surgical procedure to remove tumors from the bladder using special instruments inserted through the urethra.
Step 5
Follow-up period
Your progress will be monitored to check for any new tumors or changes in existing ones.
Regular check-ups will continue until April 2028.
The medical team will track your recovery and document any side effects from the treatment.

Who can join the trial?

10 criteria

Patient must have a suspected bladder cancer (specifically urothelial cell carcinoma Ta or T1) confirmed by medical examination
Patient must have either:
- A first-time papillary tumor (a growth that looks like a small mushroom), or
- A returning low-grade tumor (either single or multiple)
- Patient must have normal kidney function (shown by blood test results with creatinine level less than 1.12 mg/dl)
- Patient must have normal liver function shown by the following test results:
  - Gamma-glutamyl transpeptidase not higher than 51 U/L
  - Alanine aminotransferase not higher than 50 U/L
  - Total bilirubin not higher than 22 μmol/L
  - Patient must provide written consent to participate in the clinical trial
  - Both men and women may participate
  - Patient must be an adult (18 years or older)

Who cannot join the trial?

12 criteria

Age below 18 years or above 75 years
History of muscle-invasive bladder cancer (cancer that has grown into deeper layers of the bladder wall)
Previous treatment with mitomycin C (a type of chemotherapy medication) in the last 6 months
Known allergy or hypersensitivity to mitomycin C
Presence of active urinary tract infection
Pregnancy or breastfeeding
Severe kidney or liver disease
Active or uncontrolled other cancers
Inability to comply with study procedures
Medical conditions that could interfere with bladder treatment
Current participation in other clinical trials
Mental conditions that prevent understanding of informed consent

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Verified sites

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Fundacion Instituto Valenciano De Oncologia
Verified
Valencia, Spain

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Investigated drugs

Mitomycin C (MMC)
is a chemotherapy medication used to treat bladder cancer. In this trial, it is administered in two different ways: through electromotive drug administration (EMDA) before surgery, or through passive diffusion (regular instillation) after surgery. The medication works by interfering with cancer cell growth and helps prevent the cancer from returning after surgery.
Electromotive Drug Administration (EMDA)
is not a medication but a therapy method that uses a small electric current to help deliver medication (in this case, mitomycin C) more effectively into the bladder tissue. This method aims to improve how well the medication works by helping it penetrate deeper into the affected areas.

Mitomycin

What is already known about the treatment

Mitomycin-C - A chemotherapeutic medication administered through electromotive drug administration (EMDA) or passive diffusion instillation in the treatment of non-muscle invasive bladder tumors. This antibiotic-derived anticancer drug works by cross-linking DNA, thereby inhibiting DNA synthesis and cell division in cancer cells. It belongs to the class of antineoplastic antibiotics and is typically used in bladder cancer treatment protocols, either before or after transurethral resection (TUR) procedures. The medication is delivered directly into the bladder through a catheter, allowing for targeted treatment of bladder tumors while minimizing systemic side effects.

Investigated diseases

Non-muscle invasive bladder cancer - A type of bladder cancer that affects the inner lining of the bladder without penetrating into the muscle layer. The cancer begins in the cells that line the bladder's inner surface, staying within the bladder's superficial layers. It typically appears as small growths or tumors on the bladder wall. The condition can develop in multiple areas of the bladder simultaneously. These tumors may reappear in the same or different locations within the bladder over time.