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Study on the Effectiveness of Oxaliplatin or Gemcitabine Chemotherapy in Patients with Resected Pancreatic Cancer Using Standard or Genetic Allocation Methods

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 the effectiveness of chemotherapy treatments for patients with pancreatic ductal adenocarcinoma, a type of cancer that affects the pancreas. The study will compare two chemotherapy treatments: one based on oxaliplatin and the other on gemcitabine. These treatments will be given to patients who have had surgery to remove their cancer. The purpose of the study is to determine if using genetic markers to decide which treatment a patient receives is more effective than using standard clinical criteria.

Participants in the study will be randomly assigned to receive either the oxaliplatin-based or gemcitabine-based chemotherapy. The study will also include other medications such as fluorouracil, calcium folinate, irinotecan, and capecitabine. These medications are commonly used in cancer treatment and will be administered through intravenous use, except for capecitabine, which is taken orally. The study will monitor patients over a period of time to see how well they respond to the treatment and to track their disease-free survival, which means the length of time they remain free from cancer after treatment.

The trial aims to provide valuable information on whether a personalized approach using genetic markers can improve outcomes for patients with pancreatic cancer. By comparing the two methods of treatment allocation, the study hopes to find the best way to increase the time patients remain cancer-free and improve their overall survival. The study will also assess the quality of life and safety of the treatments, including any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, the patient is randomly assigned to one of two groups. This assignment is based on either standard clinical criteria or genetic markers.
The purpose of this step is to determine which chemotherapy regimen the patient will receive.
Step 2
Chemotherapy treatment
The patient receives chemotherapy treatment based on the assigned group. The treatment involves either oxaliplatin-based or gemcitabine-based chemotherapy.
Oxaliplatin is administered through an intravenous route. Gemcitabine is also administered intravenously.
Additional medications may include fluorouracil, irinotecan, calcium folinate, and capecitabine. Fluorouracil, irinotecan, and calcium folinate are given intravenously, while capecitabine is taken orally.
Step 3
Monitoring and follow-up
Throughout the treatment, the patient's health and response to the chemotherapy are closely monitored.
Regular follow-up appointments are scheduled to assess the patient's condition and to manage any side effects or complications that may arise.
Step 4
Evaluation of outcomes
The primary outcome being evaluated is disease-free survival, which measures the time from randomization to disease recurrence or death from any cause.
Secondary outcomes include overall survival, metastasis-free survival, quality of life, and safety assessments.

Who can join the trial?

16 criteria

The patient must have a type of pancreatic cancer called **pancreatic ductal adenocarcinoma** or a similar type, confirmed by a test called **histology**.
The patient must have a **creatinine clearance** of at least 50 mL/min. This is a measure of how well the kidneys are working.
If the patient is a woman who can have children, she must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after the last treatment. Men must also agree to use birth control for 6 months after the last treatment.
The time between the patient's surgery and the start of the study must be between 21 and 84 days.
The patient must have public or private health insurance.
The patient must be able to understand the nature and consequences of the clinical trial.
The patient must not be legally incapacitated, meaning they must be able to make their own decisions.
The patient must provide written consent to participate in the trial.
The patient must have provided a sample of their tumor tissue during surgery for a test called **RNAseq**.
The patient must have had a **macroscopically complete resection**, meaning the visible tumor was completely removed during surgery.
The patient must be between 18 and 79 years old.
The patient must have a **WHO performance status** of 0-1, which means they are fully active or have some symptoms but can still do light work.
The patient must not have had any previous radiotherapy or chemotherapy for pancreatic cancer.
The patient must have fully recovered from surgery and be able to receive chemotherapy, which includes eating at least 1500 calories per day and not having significant nausea or vomiting.
The patient must have adequate **hematologic function**, which means having enough white blood cells, platelets, and hemoglobin. Transfusions are allowed if needed.
The patient must have a **serum total bilirubin** level that is no more than 1.5 times the normal upper limit. This is a measure of liver function.

Who cannot join the trial?

5 criteria

Patients who have not had surgery to remove their pancreatic cancer cannot participate.
Individuals who are not receiving standard chemotherapy treatments, such as those based on oxaliplatin or gemcitabine, are excluded. These are common drugs used to treat cancer.
People who are outside the specified age range for the study cannot join. The age range is typically set to ensure safety and effectiveness of the treatment.
Participants who are not able to follow the study procedures or who have other health conditions that might interfere with the study are not eligible.
Individuals who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate. This is to ensure their safety.

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Verified sites

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

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Oxaliplatin
is a chemotherapy medication used in this trial to treat patients with pancreatic ductal adenocarcinoma. It works by interfering with the DNA in cancer cells, preventing them from growing and dividing. In this study, oxaliplatin is part of a treatment regimen to see if it can improve disease-free survival when allocated based on specific treatment criteria.
Gemcitabine
is another chemotherapy drug used in the trial for patients with pancreatic ductal adenocarcinoma. It helps to stop the growth of cancer cells by interfering with their DNA. The trial aims to determine if using gemcitabine, based on a specific treatment signature, can lead to better outcomes compared to standard allocation methods.

What is already known about the treatment

Oxaliplatin
Oxaliplatin is administered intravenously and is used in chemotherapy treatments. It is currently well-established in medical literature as a treatment for various cancers, including pancreatic cancer. The main therapeutic indication for oxaliplatin in this trial is resected pancreatic ductal adenocarcinoma. At the molecular level, oxaliplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and growing. It is classified as a platinum-based antineoplastic agent.
Gemcitabine
Gemcitabine is administered intravenously and is a standard chemotherapy medication. It is widely recognized in medical literature for its use in treating several types of cancer, including pancreatic cancer. In this trial, its primary therapeutic indication is for patients with resected pancreatic ductal adenocarcinoma. Gemcitabine acts by incorporating itself into the DNA of cancer cells, inhibiting their ability to replicate. It is classified as an antimetabolite antineoplastic agent.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is the most common form of pancreatic cancer and is known for its aggressive nature. The disease often progresses silently, with symptoms appearing only in advanced stages, which can include jaundice, weight loss, and abdominal pain. After surgical removal of the tumor, known as resection, patients may undergo additional treatments to prevent recurrence. The progression of the disease can vary, but it typically involves the spread of cancer cells to nearby tissues and organs. Early detection and intervention are crucial for managing the disease effectively.