RecruitingNAINTERVENTIONAL

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

This study is for people with pancreatic cancer that has spread to the liver, but only a few small spots. Doctors will first give a strong chemotherapy called FOLFIRINOX. After about six rounds, they'll check if the cancer has responded well. If it has, and the patient is strong enough, surgeons will then remove both the main cancer in the pancreas and the cancerous spots in the liver. The aim is to see if this combined treatment can be a good option for these patients. The study will closely watch how patients recover and if the cancer comes back, using regular scans and blood tests.

At a glance

Status

Recruiting

Phase

Sponsor

Laval University

Enrolment target

Start

16 Jan 2024

Estimated completion

16 Jan 2029

Pancreas Adenocarcinoma Pancreas Metastases Pancreas Cancer

What is this study about?

This study is looking at a new way to treat pancreatic cancer when it has spread to the liver. This type of cancer can be very challenging, especially when it has spread. Traditionally, if cancer has spread, surgery to remove it all might not be possible. However, medical advances mean doctors are always looking for better ways to help patients.

Here, doctors are investigating whether giving a powerful chemotherapy called FOLFIRINOX first can shrink both the main pancreatic tumour and the small cancer spots in the liver. If the chemotherapy works well and the tumours shrink enough, and there are only a few spots in the liver, doctors will then perform surgery to remove all the cancer they can see. This combined approach of chemotherapy followed by surgery is being explored to see if it can offer a better outcome for certain patients.

The main goal of this study is to discover if this treatment plan is safe and effective for people with pancreatic cancer that has spread to a limited number of spots in the liver. The hope is that this research will lead to improved treatments and better results for patients facing this difficult diagnosis.

Key takeaways

This study combines strong chemotherapy (FOLFIRINOX) with surgery for pancreatic cancer that has spread to the liver.
It's for patients with a limited number of small cancer spots in the liver (three or less).
Chemotherapy is given first to try and shrink the tumours before surgery.
Participation involves major surgery and ongoing follow-up with scans and blood tests.
The aim is to find better treatment options for this challenging cancer.
Open to adults 18+ who are generally fit enough for intensive treatment.

Who may be eligible?

To join this study, doctors would need to confirm you definitely have pancreatic cancer within the tubes of the pancreas. Crucially, the main tumour must be small enough to be removed by surgery, and you can only have three or fewer small cancer spots in your liver that can also be removed. It's also important that the cancer hasn't spread to any other parts of your body. You'd need to be generally fit and well enough to cope with both strong chemotherapy and a major operation like pancreatic surgery.

Before you have surgery in this study, the special chemotherapy (FOLFIRINOX) must have worked well, meaning your cancer has either shrunk or stopped growing, and specific blood tests for cancer markers have shown a good decrease. You wouldn't be able to join if your cancer has spread widely, or if you needed a very big liver operation to remove the spots, or if you can't have the chemotherapy for any reason.

This study is for adults aged 18 and over, and it's open to all genders.

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.

Do you have pancreatic cancer that started in the pancreatic ducts?
Do your doctors think your main pancreatic tumour can be removed by surgery?
Do you have three or fewer small cancer spots in your liver that could be removed?
Have regular scans shown that the cancer has not spread anywhere else in your body?
Are you generally fit and well enough for strong chemotherapy and major surgery?
Did your current chemotherapy (FOLFIRINOX) work well to shrink the cancer or keep it stable?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have detailed scans and blood tests to check if the cancer in your pancreas and liver can be removed. If you're suitable, you'll receive a total of 12 treatment cycles of chemotherapy called FOLFIRINOX. Each cycle typically takes about two weeks. After the first six cycles, you'll have more scans to see how well the chemotherapy is working. If the cancer has responded well, and you're still well enough, you'll then have surgery to remove the cancer in your pancreas and liver. The remaining six chemotherapy cycles will be given either before or after your surgery, depending on how you're tolerating the treatment and how the cancer is responding.

After your surgery, you'll have regular follow-up appointments with blood tests and scans every three or four months for at least two years. This is to keep a close eye on your health and check if the cancer returns. The total duration of active treatment and follow-up will depend on your individual response, but regular monitoring is a key part of the study.

Potential risks and benefits

Participating in this study might offer you a chance to try a treatment approach that combines strong chemotherapy with surgery, which could potentially improve your outcome compared to standard care for this type of pancreatic cancer. However, there are also risks. The chemotherapy can have significant side effects like sickness, fatigue, and other issues. Pancreatic and liver surgery are major operations with their own risks, including infection, bleeding, and a long recovery period. It's important to weigh these potential benefits and risks carefully with your medical team. You are always free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

CHU de Québec
Verified postcode
Québec, Canada· Recruiting

Common questions

What is FOLFIRINOX?

FOLFIRINOX is a strong combination of several chemotherapy drugs often used for pancreatic cancer to try and shrink it.

What does 'resectable' mean?

Resectable means that the cancer can be removed completely by surgery.

This is a special type of CT scan that takes images at different times after injecting a dye, giving doctors a detailed view of the body and organs.

What if the chemotherapy doesn't work?

If the chemotherapy doesn't shrink the cancer sufficiently, or if it grows, you would then switch to standard palliative care, which aims to manage symptoms and improve your quality of life.

Is this treatment always available?

No, this specific combination of pre-surgical FOLFIRINOX followed by surgery for limited liver spread is being studied. It's not yet a standard treatment option for everyone.

How to find out more

Alexandre Brind'Amour, MD, MSc

alexandre.brindamour.1@ulaval.ca 418-691-5370 Official trial record

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