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Study on the Safety of Tumor Treating Fields with Oxaliplatin, Calcium Folinate, Irinotecan Hydrochloride, and Fluorouracil for Metastatic Pancreatic Cancer Patients

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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 metastatic pancreatic adenocarcinoma, which is a form of pancreatic cancer that has spread to other parts of the body, such as the liver. The study is exploring a treatment combination that includes a method called Tumor Treating Fields (TTFields) along with a chemotherapy regimen known as modFOLFIRINOX. The modFOLFIRINOX treatment includes several medications: Oxaliplatin, Calcium Folinate (also known as Leucovorin Calcium), Irinotecan Hydrochloride, and Fluorouracil (also known as 5-FU). These medications are given through an intravenous route, meaning they are administered directly into the bloodstream.

The purpose of this study is to evaluate the safety of using the combination of modFOLFIRINOX and TTFields as a first-line treatment for patients with this type of cancer. Participants in the study will receive the treatment and be monitored for any side effects or adverse reactions. The study will also track how long patients can go without the cancer getting worse, as well as overall survival rates and response to the treatment. The TTFields are delivered using a device called the NovoTTF-200T system, which is designed to disrupt cancer cell division and growth.

Throughout the study, participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. This includes measuring the time the TTFields device is used during each chemotherapy cycle and evaluating the quality of life using a questionnaire. The study aims to provide valuable information on the potential benefits and risks of this treatment approach for individuals with metastatic pancreatic adenocarcinoma.

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
Initiation of treatment
The treatment begins with the administration of a combination of medications known as modFOLFIRINOX. This includes oxaliplatin, calcium folinate, irinotecan hydrochloride, and fluorouracil. All medications are given through a vein (intravenous use).
The purpose of this combination is to treat metastatic pancreatic adenocarcinoma, a type of cancer that has spread to the liver.
Step 2
Use of tumor treating fields
In addition to the medication, Tumor Treating Fields (TTFields) are used. This involves the NovoTTF-200T system, which is a device that delivers electric fields to the tumor area to disrupt cancer cell division.
The device is used continuously, and the total hours of use are recorded every 14 days during the chemotherapy cycle.
Step 3
Monitoring and evaluation
Throughout the treatment, the safety and effects of the therapy are closely monitored. This includes checking for any side effects or adverse events that may occur.
Regular assessments are conducted to evaluate the progression of the disease using imaging techniques like CT scans, following specific criteria known as RECIST 1.1.
Step 4
Quality of life assessment
The impact of the treatment on quality of life is assessed using a questionnaire called EORTC QLQ-30. This helps to understand how the treatment affects daily living and overall well-being.
Step 5
End of treatment evaluation
The treatment continues until there is disease progression or any cause-related death, whichever occurs first. The overall response to the treatment is measured by the percentage of patients who achieve complete or partial response.
The duration of disease control and overall survival are also evaluated to determine the effectiveness of the treatment.

Who can join the trial?

13 criteria

The patient must have a confirmed diagnosis of **pancreatic adenocarcinoma**, which is a type of cancer that starts in the pancreas, and it must have spread to the liver.
The patient can have had chemotherapy or radiotherapy before, but it must have been at least six months since the last treatment.
The patient must be able to use the **Novo TTF-200T System**, a medical device, either by themselves or with help from a caregiver.
The patient must have good blood and organ function, which will be checked through specific blood tests.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after the last treatment.
The patient must be 18 years old or older.
The patient or their representative must agree to participate in the study by giving consent.
The patient must be able to follow all the study requirements.
The patient must have a life expectancy of more than three months.
The patient must have cancer that has spread, with at least one liver lesion that can be biopsied, which means a small sample can be taken for testing.
The patient must have measurable disease according to specific criteria, apart from the liver lesion to be biopsied.
The patient must have an **ECOG Performance Status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must be suitable and chosen by the doctor to receive treatment with **modFOLFIRINOX**, a combination of chemotherapy drugs.

Who cannot join the trial?

4 criteria

Patients who have received previous treatment for their cancer in the metastatic stage cannot participate.
Patients with medical conditions other than pancreatic adenocarcinoma with liver metastases are not eligible.
Individuals who are not within the specified age range for the study cannot join. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not included.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital De Galdakao Usansolo
Galdakao, Spain
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Hospital Universitario Araba
Vitoria, Spain

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Investigated drugs

Tumor Treating Fields (TTFields)
are a type of therapy that uses electric fields to disrupt the division of cancer cells. In this trial, TTFields are applied using a device called the NovoTTF-200T system. This therapy is being tested to see if it can help treat metastatic pancreatic cancer when used alongside other treatments.
modFOLFIRINOX
is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes several medications that work together to stop cancer cells from growing and dividing. This combination is being tested in the trial to see how well it works with TTFields for treating metastatic pancreatic cancer.

What is already known about the treatment

Tumor Treating Fields (TTFields)
This treatment is administered using a device called the NovoTTF-200T system, which delivers low-intensity, alternating electric fields to the tumor site. It is currently being studied in clinical trials for its safety and effectiveness in treating metastatic pancreatic adenocarcinoma. The main therapeutic indication is for patients with pancreatic cancer that has spread to the liver and who have not received prior systemic treatment for their metastatic disease. TTFields work by disrupting cancer cell division at the molecular level, thereby inhibiting tumor growth. It is classified as a non-invasive cancer therapy.
modFOLFIRINOX
This is a combination chemotherapy regimen administered intravenously, consisting of modified doses of several drugs. It is being evaluated in clinical trials for its use in treating metastatic pancreatic adenocarcinoma, particularly in combination with TTFields. The main therapeutic indication is for patients with pancreatic cancer that has metastasized to the liver. The mechanism of action involves interfering with DNA replication and cell division, leading to cancer cell death. It is classified as a chemotherapy treatment.

Investigated diseases

Pancreatic Adenocarcinoma – This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often starts in the ducts that carry digestive enzymes out of the pancreas. As the disease progresses, it can spread to nearby organs and tissues, including the liver, which is a common site for metastasis. The cancer cells grow uncontrollably, forming a mass or tumor, and can interfere with the normal functions of the pancreas and other organs. Symptoms may not appear until the disease is advanced, making early detection challenging. The progression of the disease can lead to complications such as jaundice, weight loss, and digestive issues.