Recruiting

Study on Bladder Cancer: Testing Cisplatin and Drug Combination for 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 is focused on studying a type of bladder cancer known as non-muscle invasive bladder cancer. The study aims to evaluate the effectiveness of a treatment approach that involves administering chemotherapy directly into the bladder before a surgical procedure called transurethral resection of the bladder (TURBT). This approach is being tested to see if it can help prevent the cancer from coming back.

The trial involves several chemotherapy medications, including cisplatin, doxorubicin hydrochloride, mitomycin, gemcitabine, docetaxel, and epirubicin hydrochloride. These medications are known as chemotherapeutic agents, which are drugs used to kill or stop the growth of cancer cells. In this study, these drugs are given directly into the bladder, a method known as intravesical use, to see if they can reduce the chances of the cancer returning after surgery.

The purpose of the study is to compare the rate of early cancer recurrence between patients who receive this chemotherapy treatment before surgery and those who undergo the surgery without the chemotherapy. Participants in the study will be randomly assigned to one of these two groups. The study will also monitor any side effects of the drugs used. The trial is expected to continue for several years to gather enough information to determine the effectiveness of this treatment approach.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the bladder cancer.
This may include clinical examinations and imaging tests to confirm the presence of non-muscle invasive bladder cancer.
Step 3
Treatment phase
The treatment involves intravesical instillation of neoadjuvant chemotherapy before the surgical procedure known as transurethral resection of the bladder tumor (TURBT).
Medications used include cisplatin, doxorubicin hydrochloride, mitomycin, gemcitabine, docetaxel, and epirubicin hydrochloride. These are administered directly into the bladder.
The specific dosage and frequency of administration are determined by the medical team based on individual patient needs.
Step 4
Surgical procedure
The TURBT procedure is performed to remove the bladder tumor.
This is a standard procedure for treating non-muscle invasive bladder cancer.
Step 5
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor the patient's recovery and check for any signs of cancer recurrence.
These appointments may include clinical evaluations and imaging tests.
Step 6
Completion of the study
The study is expected to conclude by May 2029.
Final assessments are conducted to evaluate the effectiveness of the treatment and any long-term effects.

Who can join the trial?

6 criteria

Patients of both sexes aged 18 years or older.
Patients with clinical or imaging evidence of **CVNMI** (a type of bladder cancer) who need a procedure called **TURBT** (a surgery to remove bladder tumors).
Patients with a history of **CVNMI** at stages Ta/T1, G1-G3, without **CIS** (a specific type of bladder cancer) and have been free of the disease for at least 6 months.
A **Karnofsky scale** score greater than 70%. This scale measures a patient's ability to perform everyday activities, with higher scores indicating better ability.
Patients who agree to participate in the study by signing the informed consent form.
Patients with tumors smaller than 3 cm.

Who cannot join the trial?

7 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 previous **neoadjuvant chemotherapy** are excluded. Neoadjuvant chemotherapy is treatment given before the main treatment to shrink a tumor.
Patients with other types of cancer that are not under control or have not been treated successfully cannot join.
Patients with serious health conditions that could interfere with the study or make it unsafe for them to participate are not allowed.
Pregnant or breastfeeding women cannot take part in the study.
Patients who are unable to follow the study procedures or attend the required visits are excluded.
Patients who are participating in another clinical trial at the same time are not eligible.

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Verified sites

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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Araba
Verified
Vitoria, Spain
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain

Trial locations

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Investigated drugs

Neoadjuvant Chemotherapy
is a treatment given before the main treatment. In this trial, it is used to treat bladder cancer by being directly placed into the bladder. This approach aims to reduce the risk of cancer coming back after surgery. The chemotherapy works by killing cancer cells or stopping them from growing and spreading.
Transurethral Resection of Bladder Tumor (TURBT)
is a surgical procedure used to remove bladder tumors. It involves inserting a small tool through the urethra to reach the bladder and remove the tumor. This method is commonly used to treat nonmuscle-invasive bladder cancer and is part of the standard treatment approach.

What is already known about the treatment

Neoadjuvant Chemotherapy – This medication is administered directly into the bladder through a process known as intravesical instillation. It is currently being studied in clinical trials for its effectiveness in preventing the recurrence of non-muscle invasive bladder cancer. The main therapeutic indication is to reduce early recurrences of bladder cancer when used before surgical removal of the tumor. At the molecular level, it works by interfering with the DNA of cancer cells, preventing them from multiplying. It is classified pharmacologically as a chemotherapy agent.

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 yet invaded the muscle layer. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease is typically detected through urine tests and imaging studies. It progresses by potentially growing into larger tumors or spreading to other parts of the bladder lining. The risk of recurrence is a significant concern, and monitoring is essential to manage the disease effectively. Regular follow-ups are necessary to check for any signs of progression or recurrence.