RecruitingPHASE2INTERVENTIONAL

Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy

This research study is looking at how effective and safe a chemotherapy treatment called FOLFIRINOX is for people with pancreatic cancer. It's for patients whose cancer has either spread to other parts of the body (metastatic) or is locally advanced and can't be removed by surgery. This study aims to see if giving FOLFIRINOX as the very first chemotherapy treatment helps these patients. We'll be giving the treatment in cycles and then a maintenance phase, carefully monitoring patients throughout. The goal is to gather more information to help improve care for people with this type of cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Georges Francois Leclerc

Enrolment target

Start

24 Jan 2024

Estimated completion

24 Jul 2029

Metastatic Pancreatic Cancer

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. The main goal here is to investigate a specific chemotherapy treatment called FOLFIRINOX. This treatment is already known and used for certain cancers, but this study wants to understand its benefits and safety when given as the first treatment for pancreatic cancer that has spread or can't be surgically removed.

Pancreatic cancer can be a challenging disease. When cancer cells spread beyond the pancreas or are too extensive to be taken out by an operation, doctors look for other ways to treat it. Chemotherapy uses medicines to kill cancer cells or slow their growth. FOLFIRINOX is a combination of different chemotherapy drugs. By studying it in this way, researchers hope to learn if this particular approach can offer a good treatment option for patients.

Doctors and researchers want to find the best possible ways to help people with pancreatic cancer live longer and with a better quality of life. This study is an important step in gathering more evidence about how effective and safe FOLFIRINOX is in this specific situation, which could help guide future treatment decisions for many patients.

Key takeaways

This study evaluates FOLFIRINOX chemotherapy for pancreatic cancer that can't be surgically removed or has spread.
It's for people who haven't had chemotherapy for their cancer before.
You'll receive chemotherapy treatments and regular monitoring (scans, blood tests).
There are strict health checks to make sure the treatment is safe for you.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult over 18 years old. Your pancreatic cancer must be an adenocarcinoma type and either locally advanced and not suitable for surgery, or it must have spread to other parts of your body. Importantly, you shouldn't have had chemotherapy for this cancer before, though some past chemotherapy given after surgery might be okay if it was more than a year ago.

Your general health needs to be good enough to handle the treatment, which includes having a good 'performance status' (meaning you're fairly active and able to do most daily tasks). You also need to meet specific health requirements for taking FOLFIRINOX, such as having a healthy heart and controlled blood pressure. Pregnant women would not be able to take part.

There are also reasons why you might not be able to join. For example, if you have other specific types of cancer, particular types of brain tumours, or if your doctors believe your prognosis (outlook) is less than three months. The study doctors would carefully check all these details to see if this study is right and safe for you.

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 over 18 years old?
Do you have pancreatic cancer (adenocarcinoma type) that has spread or can't be removed by surgery?
Have you *not* had chemotherapy for your cancer before (some exceptions may apply)?
Is your general health good enough to receive chemotherapy (e.g., active and able to do most daily tasks)?
Do you have controlled blood pressure and no specific heart issues that would prevent FOLFIRINOX?
Are you able to attend all planned hospital visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the FOLFIRINOX chemotherapy treatment. This involves a maximum of 16 treatment sessions, given in two blocks of eight sessions. After these initial treatments, you would go onto a maintenance treatment, which includes specific drugs (folinic acid/calcium levofolinate and 5-FU). This maintenance treatment would continue as long as the cancer isn't progressing.

Throughout the study, you would have regular visits to the clinic. These visits will involve important checks like blood tests and scans (like CT scans) to see how you're responding to the treatment and to monitor for any side effects. You'll need to follow the study schedule carefully, attending all planned appointments and examinations. The doctors and nurses will explain how long your involvement is expected to be, including treatment and follow-up checks, and what each step involves.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as gaining access to a new or different way of using an established treatment under close medical supervision. The aim is to see if this treatment can help manage your cancer. However, all medical treatments, especially chemotherapy, carry potential risks and side effects, which can range from mild to severe. These will be thoroughly explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Georges-François Leclerc
Verified postcode
Dijon, France· Recruiting

Common questions

What is FOLFIRINOX?

FOLFIRINOX is a combination of several different chemotherapy drugs used to treat certain cancers.

What does 'unresectable' mean?

It means the cancer can't be completely removed by surgery, either because of its size, location, or if it has grown into important blood vessels.

What is 'metastatic pancreatic cancer'?

This means your pancreatic cancer has spread from where it started to other parts of your body.

Will I get FOLFIRINOX for free if I join?

Yes, treatments given as part of a clinical trial are typically provided at no direct cost to the patient.

Can I stop the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your medical care.

How to find out more

Jean-David FUMET, Dr

jdfumet@cgfl.fr 380737538 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.