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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Krankenhaus Nordwest GmbH Frankfurt Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Research Organisation GmbH Berlin Germany
Heidelberg University Mannheim Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Katholisches Klinikum Bochum gGmbH Bochum Germany
Lrqtk Uyeajlyglsdi Mdjhxqn Cwzxmku (diwjf Leiden The Netherlands
Uimrwlzucy Hfzqgyju Cixnwus Cologne Germany
Ajurankyg Uve Amsterdam The Netherlands
Hdbnmotj Ukrexaesnx Ctmplye Hlqtjrew Helsinki Finland
Emduzrn Uzboyjfxubtz Mrzzshu Cvbffhe Rbbxyddgr (pxgsoza Msk Rotterdam The Netherlands
Ufdtdbipcuknxehpfjbrc Mxgezyvn Arh Munster Germany
Gueice Uaodffdbft Fxwwvjxhr Frankfurt Germany
Kdoswoja dqa Uvdjzcwonpph Mwjsrlbb Aox Munich Germany
Usjuemnkobwcbbmqzzhqg Wdxdnfrop Axp Wuerzburg Germany
Uieaomhgcm Mexlfku Coibmk Hipwrseusobgrwadi Hamburg Germany
Uxqialgclzsoecbjeaeai Elgbb Axi Essen Germany
Mstllylakjtqmloccjuyqgocpc Hutqwngelqttempk Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
31.03.2023
Germany Germany
Recruiting
31.03.2023
Sweden Sweden
Recruiting
31.03.2023
The Netherlands The Netherlands
Not yet recruiting
31.03.2023

Trial locations

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.

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 ID:
2023-503558-10-00
Protocol code:
1.3
Trial Phase:
Therapeutic confirmatory (Phase III)

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