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

1 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital De Galdakao Usansolo	Galdakao	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Araba	Vitoria	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2025

Trial locations

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.

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.

Trial ID:

2024-511459-16-00

Protocol code:

NOVOFFOX

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?