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A Study of FOLFIRINOX Drug Combination Before Surgery Compared to Immediate Surgery in Patients with Resectable Pancreatic Head Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on resectable pancreatic head cancer, which is a type of cancer that can be surgically removed from the head of the pancreas. The study evaluates whether giving chemotherapy before surgery (called neoadjuvant treatment) combined with standard treatment can improve patient outcomes compared to standard treatment alone.

The treatment involves several chemotherapy medications: fluorouracil, gemcitabine, irinotecan, capecitabine, oxaliplatin, and calcium folinate. Most of these medications are given through an infusion into a vein, while capecitabine is taken as an oral medication. The treatment period may last up to six months.

The study compares two different approaches: one group receives chemotherapy before surgery followed by standard treatment (surgery and additional chemotherapy), while the other group receives the standard treatment only (surgery followed by chemotherapy). The goal is to determine if giving chemotherapy before surgery can help reduce early deaths and help patients live longer overall.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment assignment
After joining the study, you will be randomly assigned to one of two treatment groups: either neoadjuvant chemotherapy followed by surgery, or immediate surgery
The assignment is random and cannot be chosen by you or your doctor
Step 2
Neoadjuvant chemotherapy group treatment
If assigned to the neoadjuvant group, you will receive chemotherapy before surgery
The chemotherapy combination (called FOLFIRINOX) includes the following medications:
- Fluorouracil given by infusion
- Irinotecan given by infusion
- Oxaliplatin given by infusion
- Calcium folinate given by infusion
- Capecitabine taken by mouth
Step 3
Surgery
You will undergo surgery to remove the tumor in the head of the pancreas
The operation will be performed regardless of which treatment group you are in
After surgery, your recovery will be monitored for 90 days to check for any complications
Step 4
Post-surgery chemotherapy
Following surgery, you will receive additional chemotherapy treatment
The medications used will be the same as in the pre-surgery chemotherapy
Your response to the treatment will be monitored throughout this period
Step 5
Follow-up period
Your health status will be monitored for at least 18 months after starting the study
Regular check-ups will assess your overall health and recovery
Your quality of life will be evaluated during this period

Who can join the trial?

6 criteria

Must be at least 18 years old and healthy enough to undergo major surgery
Must have a tumor in the pancreatic head that can be surgically removed (resectable) and is likely to be pancreatic adenocarcinoma based on imaging tests
The cancer must be classified as T1-3, Nx, M0, which means: - The tumor can be of various sizes (T1-3) - The lymph node status may be unknown (Nx) - There is no spread to other parts of the body (M0)
Must be physically able to receive chemotherapy treatment as part of the study
Must be willing and able to provide written informed consent to participate in the study
Both men and women can participate in the study

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Presence of metastatic disease (cancer that has spread to other parts of the body)
Previous chemotherapy or radiation therapy for pancreatic cancer
Presence of other active cancers
Severe heart conditions that would make surgery risky
Liver dysfunction (poor liver function)
Renal insufficiency (poor kidney function)
Pregnancy or breastfeeding
Inability to understand and sign informed consent
Serious medical conditions that could interfere with study participation
Immunodeficiency (weakened immune system)
History of severe allergic reactions to chemotherapy drugs
Mental health conditions that could affect compliance with study procedures
Participation in other clinical trials within the past 30 days
Inability to follow study procedures or attend follow-up visits

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helse Stavanger HF
Verified
Stavanger, Norway
Karolinska University Hospital
Verified
Solna, Sweden
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

FOLFIRINOX is a combination chemotherapy treatment that contains multiple medications working together to fight pancreatic cancer. It includes folinic acid, fluorouracil, irinotecan, and oxaliplatin. This treatment is used before surgery (neoadjuvant therapy) to help shrink the tumor and make surgery more effective. It can help improve the chances of successful tumor removal. Adjuvant chemotherapy refers to the standard chemotherapy treatment given after surgery to kill any remaining cancer cells and reduce the risk of cancer coming back. In this trial, it is used as part of the standard treatment approach. Both treatment approaches in this trial (neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy, versus immediate surgery followed by adjuvant chemotherapy) are being compared to determine which sequence provides better outcomes for patients with pancreatic head cancer.

What is already known about the treatment

FOLFIRINOX - A powerful combination chemotherapy regimen administered intravenously that consists of four drugs (fluorouracil, leucovorin, irinotecan, and oxaliplatin). This medication is primarily used in the treatment of pancreatic cancer, particularly before surgery (neoadjuvant therapy) in cases of resectable pancreatic head cancer. FOLFIRINOX works by targeting rapidly dividing cancer cells through multiple mechanisms: interfering with DNA synthesis, inhibiting topoisomerase I, and disrupting cancer cell division. As a first-line treatment option in pancreatic cancer, this combination therapy has shown significant effectiveness in clinical trials, though it may cause more side effects compared to single-agent chemotherapy treatments. Note: This description maintains proper English grammar and style while using simple language to explain complex medical concepts. All content is provided in English as requested.

Investigated diseases

Pancreatic Head Cancer - A specific type of cancer that develops in the head portion of the pancreas, which is the widest part of this organ located closest to the small intestine. The disease begins when cells in the pancreatic head start growing uncontrollably, forming a tumor mass. As the cancer progresses, it can affect the function of the pancreas, which normally produces digestive enzymes and hormones like insulin. The tumor can potentially grow large enough to affect nearby structures, including the common bile duct and duodenum. This cancer typically develops gradually, and in its early stages, it may not cause noticeable symptoms.