RecruitingPHASE2INTERVENTIONAL

Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

This study is for people with a specific type of pancreatic cancer that is borderline resectable, meaning it's difficult but not impossible to remove with surgery. The main aim is to see if giving chemotherapy (either mFOLFIRINOX or Gemcitabine / Nab-paclitaxel) before surgery (called neoadjuvant chemotherapy) is a practical and safe approach. Researchers will also look at how many patients complete all parts of the treatment, including the surgery itself. They'll be checking how well patients tolerate the treatment and if there are any serious side effects. This trial hopes to find better ways to manage this challenging cancer. It is not comparing different treatments, but focusing on the feasibility of this specific treatment order.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

Start

01 Mar 2021

Estimated completion

01 May 2026

Pancreatic Adenocarcinoma

What is this study about?

This study, called "Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery," is looking into a new way to treat a specific type of pancreatic cancer. Pancreatic cancer can sometimes be very difficult to treat, especially when it's grown close to important blood vessels. Doctors call this 'borderline resectable' – it means surgery might be possible, but it's very challenging to remove all of the cancer safely.

The main idea behind this study is to give patients chemotherapy *before* they have surgery. This is called 'neoadjuvant chemotherapy'. The hope is that the chemotherapy will shrink the tumour, making it easier and safer for surgeons to remove it completely. In this study, doctors are using two different chemotherapy combinations: mFOLFIRINOX or Gemcitabine / Nab-paclitaxel.

This isn't a study that compares different treatments against each other. Instead, it's a 'Phase 2' study, which means the doctors are mainly trying to find out if this treatment plan (chemotherapy first, then surgery) is practical and safe. They'll be watching closely to see how many patients can complete all the steps, including the chemotherapy and the surgery, and if there are any unexpected problems. The results will help doctors understand if this approach could be a good option for future patients.

Key takeaways

This study evaluates chemotherapy given before surgery for a challenging type of pancreatic cancer.
It aims to see if this treatment approach is practical and safe for patients.
Two types of chemotherapy, mFOLFIRINOX or Gemcitabine / Nab-paclitaxel, are being used.
The study includes chemotherapy, followed by surgery, and potentially more chemotherapy after.
Patients will be carefully monitored for side effects and followed up for up to two years.
This is a 'Phase 2' study, focusing on the feasibility of the treatment plan.

Who may be eligible?

To join this study, generally, you need to be an adult between 18 and 79 years old with a confirmed diagnosis of this specific type of pancreatic cancer (borderline resectable pancreatic adenocarcinoma). Your doctors must also believe you are well enough to have surgery, and your general health, including your blood counts, kidney, and liver function, needs to be within healthy limits.

There are also some reasons why you might not be able to join. For example, if your cancer has already spread to other parts of your body, or if you've already had radiation treatment to your pancreas. Certain heart conditions, ongoing infections, or nerves problems (neuropathy) could also mean this study isn't right for you. Unfortunately, if you are pregnant, you cannot take part.

Before you can join, the study team will carry out detailed checks to make sure the study is suitable and safe for you. They will explain everything clearly and answer all your questions.

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 between 18 and 79 years old?
Have you been diagnosed with 'borderline resectable' pancreatic cancer?
Are your doctors confident you are well enough for surgery?
Do you have good overall health, including normal blood, kidney, and liver test results?
Have you *not* had your cancer spread to other parts of your body?
Are you *not* pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive chemotherapy. This will be either mFOLFIRINOX or Gemcitabine / Nab-paclitaxel, given over several weeks. After your chemotherapy, you'll have a scan, usually a CT scan, to see how the treatment has worked. If the doctors decide it's safe and appropriate, you will then have an operation to remove the pancreatic tumour (pancreatectomy).

Following your surgery, you might also have more chemotherapy, called 'adjuvant chemotherapy'. Doctors will also keep a close eye on you after the operation for any problems for up to 90 days. After this, you will have regular follow-up appointments, including CT scans of your chest and tummy, every four months for two years. If for any reason you don't have the surgery, you will still be followed up for two years to monitor your health. The total duration of your participation will depend on your treatment path, but follow-up could last up to two years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the chemotherapy before surgery might shrink the tumour, making the surgery more successful and potentially improving your outcome. However, chemotherapy can cause side effects like tiredness, nausea, and changes to blood counts. Surgery also carries risks, including infection and bleeding. The study team will carefully monitor you for any side effects or complications. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Juravinski Hospital
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What does 'borderline resectable' mean?

It means the cancer is very close to important blood vessels, making surgery tricky but still potentially possible.

What is 'neoadjuvant chemotherapy'?

This is chemotherapy given before surgery, often to shrink a tumour and make the operation easier.

Will I definitely have surgery if I join this study?

The plan is to have surgery after chemotherapy, but this depends on how the chemotherapy works and if doctors think surgery is still safe and appropriate for you.

What are mFOLFIRINOX and Gemcitabine / Nab-paclitaxel?

These are specific combinations of chemotherapy drugs used to treat pancreatic cancer.

How long will I be followed up after treatment?

You will be followed up with scans and appointments for up to two years after your surgery or the start of the study.

How to find out more

Leyo Ruo, MD

ruol@mcmaster.ca 905-521-2100 Official trial record

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