Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on Treatment Options for Patients with Oligometastatic Pancreatic Cancer: Comparing Oxaliplatin, Fluorouracil, Folinic Acid, and Drug Combination

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 known as oligometastatic pancreatic cancer. This condition involves cancer that has spread from the pancreas to a limited number of other areas, such as the liver. The trial aims to compare two different treatment approaches to see which one is more effective in improving the survival of patients. One group of patients will receive a combination of medications known as mFOLFIRINOX, which includes Oxaliplatin, Fluorouracil, Calcium Folinate, and Irinotecan. These medications are given through an injection into a vein. The other group will receive the same combination of medications followed by surgery to remove the cancer.

The purpose of the study is to determine if patients who receive the combination of medications followed by surgery have a better chance of living longer compared to those who receive only the medication. The study will involve regular visits to the clinic for treatment and monitoring. Patients will be randomly assigned to one of the two groups, and some may receive a placebo as part of the study. The study will last for a period of up to 24 months, during which patients will be closely monitored for any changes in their condition and any side effects from the treatment.

Throughout the study, the health and quality of life of the participants will be assessed. This includes looking at how long patients live without the cancer getting worse and any complications that may arise from the treatments. The study will also evaluate the safety of the treatments, including the surgical removal of the tumor and any cancer that has spread. The goal is to gather information that could help improve treatment options for patients with oligometastatic pancreatic cancer in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide written consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to one of two groups: one receiving **multimodal surgical treatment** or the other receiving **systemic chemotherapy alone**.

  4. Step 4

    Chemotherapy administration

    If assigned to the chemotherapy group, you will receive a combination of medications: **oxaliplatin**, **fluorouracil**, **calcium folinate**, and **irinotecan**. These medications are administered through direct intravenous injection.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

  5. Step 5

    Surgical treatment

    If assigned to the surgical treatment group, you will undergo surgery following the chemotherapy regimen. The surgery aims to remove the primary tumor and any treatable liver metastases.

  6. Step 6

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor your health, evaluate the treatment's effectiveness, and identify any side effects. These assessments may include physical exams, imaging tests, and laboratory tests.

  7. Step 7

    Completion of the study

    Upon completion of the study, a final assessment will be conducted. You will be informed about the study's findings and any further steps regarding your treatment and care.

Who can join the trial?

11 criteria

  • Age between 18 and 80 years.
  • Diagnosis of pancreatic cancer that has spread to other parts of the body, confirmed by a doctor through tests.
  • The main tumor in the pancreas can be operated on safely.
  • Limited spread to the liver, with 3 or fewer liver spots that can be removed or treated. If the cancer spread after initial treatment, it must have been at least 6 months since the last chemotherapy.
  • Previous cancer treatment for non-spread pancreatic cancer is allowed if the last treatment was given at least 6 months before starting this study.
  • Good blood health, with white blood cells (WBC) of at least 3000/µl, platelets of at least 100,000/µl, and hemoglobin of at least 8 g/dl.
  • Good liver health, with bilirubin levels no more than 2.5 times the normal limit.
  • Good kidney health, with creatinine clearance greater than 50 ml/min.
  • Ability to perform daily activities with an ECOG performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
  • Willingness to sign a written consent form, agreeing to participate in the study, according to international and local laws.
  • Presence of measurable disease according to RECIST v1.1 criteria before starting treatment, which means the cancer can be measured by scans or tests.

Who cannot join the trial?

3 criteria

  • Patients who do not have oligometastatic pancreatic cancer cannot participate. This means the cancer has spread to a limited number of other places in the body.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate. This typically includes groups like children, pregnant women, or those unable to give consent.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

mFOLFIRINOX is a combination of several chemotherapy drugs used to treat pancreatic cancer. It includes four different medications that work together to stop cancer cells from growing and spreading. This treatment is often used when the cancer is advanced or has spread to other parts of the body. The goal of mFOLFIRINOX is to shrink the tumors and improve the patient's overall survival. In this trial, mFOLFIRINOX is used both as a standalone treatment and in combination with surgery to see which approach is more effective for patients with a specific type of pancreatic cancer.

What is already known about the treatment

mFOLFIRINOX – mFOLFIRINOX is a combination chemotherapy regimen administered intravenously, meaning it is given through a vein. It is currently used in the treatment of pancreatic cancer, specifically in cases where the cancer has spread to a limited number of other sites, known as oligometastatic pancreatic cancer. The main goal of this treatment is to improve overall survival by using a combination of drugs that work together to stop cancer cells from growing and dividing. At the molecular level, these drugs interfere with the DNA and RNA of cancer cells, preventing them from multiplying. mFOLFIRINOX is classified as an antineoplastic or anticancer chemotherapy regimen.

Investigated diseases

Oligometastatic Pancreatic Cancer – Oligometastatic pancreatic cancer is a form of pancreatic cancer where the disease has spread to a limited number of other sites in the body. It typically originates in the pancreas, an organ responsible for producing digestive enzymes and hormones like insulin. The progression of this disease involves the growth of cancerous cells in the pancreas, which can then metastasize, or spread, to other parts of the body, but only to a few specific areas. This limited spread distinguishes it from more widespread metastatic cancer. The disease can lead to symptoms such as abdominal pain, weight loss, and jaundice as it progresses. The behavior of the cancer cells and their ability to invade other tissues can vary, influencing the course of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503558-10-00Protocol code1.3Estimated enrolment500 patientsSponsorUniversitaetsmedizin Goettingen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.