AuthorisedTherapeutic confirmatory (Phase III)Interventional

Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study

This research study, called PREOPANC-3, is investigating the best timing for a powerful chemotherapy drug combination called FOLFIRINOX in people with pancreatic cancer. Specifically, it's comparing if giving FOLFIRINOX chemotherapy before surgery (perioperative) works better than giving it after surgery (adjuvant). The main goal is to find out which approach helps people live longer. This study is for adults aged 18 and over who have pancreatic cancer that hasn't spread to other parts of the body and can be surgically removed. The FOLFIRINOX treatment involves a mix of several chemotherapy drugs. This is a large, advanced-stage study, meaning it’s designed to confirm if one treatment is more effective than the other.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

378

Start

06 Sep 2024

Non-metastatic resectable pancreatic cancer

What is this study about?

This study, known as PREOPANC-3, is focused on finding the best way to treat a specific type of pancreatic cancer. Pancreatic cancer can be a challenging disease, and for some people, surgery to remove the tumour is an important part of their treatment. This study is for those whose cancer has not spread and can be removed through surgery.

The researchers are looking at a strong chemotherapy treatment called FOLFIRINOX. This treatment is made up of several different medications, all working together to kill cancer cells. The main question this study wants to answer is whether giving this chemotherapy *before* surgery is more effective than giving it *after* surgery. Both approaches are currently used in cancer care, but we don't yet know for sure which one leads to better long-term results for patients.

By comparing these two timings – chemotherapy first, then surgery, versus surgery first, then chemotherapy – the study aims to discover which sequence helps people live longer. The hope is that the findings from PREOPANC-3 will improve treatment plans for future patients with this type of pancreatic cancer, helping them achieve the best possible outcomes.

Key takeaways

Compares chemotherapy before vs. after surgery for pancreatic cancer.
Focuses on pancreatic cancer that can be surgically removed.
Uses a strong chemotherapy called FOLFIRINOX.
Aims to find out which treatment timing helps people live longer.
For adults aged 18 and over.
Helps improve future treatment for pancreatic cancer.

Who may be eligible?

This study is looking for volunteers who are 18 years of age or older. Both men and women can take part.

To be eligible, you must have pancreatic cancer that has not spread to other parts of your body. Importantly, your cancer must also be suitable for removal through surgery.

There will be other medical checks and criteria that a study doctor will discuss with you to make sure this study is safe and appropriate for your specific health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your doctor told you that you have pancreatic cancer?
Has your doctor confirmed that your cancer has not spread?
Has your doctor confirmed that your cancer can be removed with surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a specific chemotherapy treatment called FOLFIRINOX. This involves a combination of several medications given as an infusion, typically through a drip. Depending on which treatment group you are in, you will receive this chemotherapy either before or after your surgery.

You will have regular visits to the hospital for your chemotherapy treatments, as well as appointments for health checks, blood tests, and scans. These visits are important to monitor your health, how the treatment is working, and to manage any side effects you might experience. The total duration of your participation, including follow-up appointments after your main treatment and surgery, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of receiving advanced cancer treatment and being closely monitored by a specialist medical team. You would also be contributing to medical knowledge that could help future patients. However, like all medical treatments, FOLFIRINOX chemotherapy can have side effects, which vary from person to person. These will be fully explained to you before you decide to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands
—
Unverified
Sweden

Common questions

What is FOLFIRINOX?

FOLFIRINOX is a strong combination of several chemotherapy drugs used to treat certain cancers, including pancreatic cancer. It's given through a drip.

What does 'resectable pancreatic cancer' mean?

It means the pancreatic cancer has not spread to other parts of the body and can be surgically removed by an operation.

Will I definitely get the treatment before surgery?

Because this is a comparison study, you will either receive the chemotherapy before surgery or after surgery. The study team will explain how this decision is made.

Are there any costs for taking part?

You will not have to pay for the study treatment or extra tests related to the study. Any travel expenses might be reimbursed; please check with the study team.

How long will I be followed up in the study?

The study involves a period of active treatment and then follow-up appointments. The full length of your participation, including follow-up, will be clearly explained by the research team.