Study comparing FOLFIRINOX versus gemcitabine-based chemoradiotherapy in patients with resectable or borderline resectable pancreatic cancer

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What is this study about?

This clinical trial focuses on patients with pancreatic cancer that is (borderline) resectable and has not spread to other parts of the body. The study compares two different treatment approaches for this type of cancer. The first treatment approach uses a combination of medications called FOLFIRINOX, which includes fluorouracil, folinic acid, irinotecan, and oxaliplatin. The second treatment approach uses gemcitabine combined with radiation therapy.

The purpose of this study is to determine if giving FOLFIRINOX before surgery leads to better survival rates and quality of life compared to giving chemotherapy with radiation before surgery followed by gemcitabine after surgery. Both treatments are given through an infusion, which means the medications are delivered directly into the bloodstream through a vein.

The treatment plan involves receiving either FOLFIRINOX or gemcitabine with radiation therapy before surgery. After surgery, patients in the second group will receive additional treatment with gemcitabine. The total treatment period may last up to 44 weeks, depending on which treatment group the patient is assigned to.

1 Initial diagnosis confirmation

A histological or cytological confirmation of pancreatic cancer will be performed

Medical evaluation will confirm your eligibility based on specific health criteria, including blood tests showing adequate levels of white blood cells, platelets, and hemoglobin

Your kidney function will be assessed through an E-GFR test which must be above 50 ml/min

2 Treatment path assignment

You will be assigned to one of two treatment paths:

Path 1: FOLFIRINOX treatment before surgery

Path 2: Chemotherapy combined with radiation therapy before surgery, followed by additional treatment after surgery

3 Pre-surgery treatment – Path 1

If assigned to Path 1, you will receive FOLFIRINOX, which includes:

– Irinotecan through infusion

– Folinic acid through infusion

– Oxaliplatin through infusion

– Fluorouracil through infusion

4 Pre-surgery treatment – Path 2

If assigned to Path 2, you will receive:

Gemcitabine through infusion combined with radiation therapy

5 Surgery

After completing the pre-surgery treatment, a surgical procedure will be performed to remove the tumor

6 Post-surgery treatment – Path 2

If you were assigned to Path 2, you will receive additional gemcitabine treatment through infusion after surgery

7 Follow-up period

Regular check-ups will be conducted to monitor your progress

The study will continue until June 2026

Who Can Join the Study?

You must have confirmed pancreatic cancer through tissue or cell examination
You must provide written informed consent to participate in the study
Your cancer must be (borderline) resectable (possible to remove with surgery) and must not have spread to other parts of the body
Your physical performance status must be good (able to carry out all normal activity or only restricted in physically strenuous activity)
You must be healthy enough to undergo surgery, chemotherapy and radiation therapy
Your white blood cell count must be at least 3.0 X 109/l
Your blood platelet count must be at least 100 X 109/l
Your hemoglobin level (oxygen-carrying protein in blood) must be at least 6 mmol/l
Your kidney function must be adequate (filtration rate above 50 ml/min)
You must be 18 years or older

Who Cannot Join the Study?

Age below 18 years or above 75 years
Presence of metastatic disease (cancer that has spread to other parts of the body)
Previous treatment with chemotherapy (medications used to kill cancer cells) or radiation therapy for pancreatic cancer
Pregnant or breastfeeding women
Severe heart conditions or recent heart attack (within last 6 months)
Severe kidney problems (creatinine clearance less than 50 mL/min)
Severe liver problems
Active, uncontrolled infections
Known allergies to any of the study medications
Participation in other clinical trials within the last 30 days
Mental conditions that could interfere with following study procedures
Any other serious medical condition that could affect participation in the study

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Reinier de Graaf Groep	Delft	The Netherlands
Lffmv Uhnxsfaaygqa Melpeaz Cieurnz (ppwny	Leiden	The Netherlands
Aqqsslnnp Uxm	Amsterdam	The Netherlands
Euzpbhc Uuqnsubmrmhb Mnziljs Cdzaczv Ruxslasag (yvwihic Mtk	Rotterdam	The Netherlands
Sfj Ebkgkfywq Hsaxbits Tjsjiif	Tilburg	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.06.2018

Trial locations

Investigated drugs:

FOLFIRINOX is a combination chemotherapy treatment that contains multiple medications working together to fight pancreatic cancer. It is used before surgery (neoadjuvant therapy) to help shrink the tumor and improve surgical outcomes.

Gemcitabine is a chemotherapy medication used in combination with radiation therapy (chemoradiotherapy) before surgery, and also given alone after surgery (adjuvant therapy). It works by interfering with cancer cell growth and division.

Radiation therapy is a treatment that uses high-energy beams to target and destroy cancer cells. In this trial, it is combined with gemcitabine before surgery as part of the chemoradiotherapy approach.

Investigated diseases:

Pancreatic carcinoma

Pancreatic Cancer – A condition that begins when abnormal cells start growing in the pancreas, forming a tumor. The disease typically develops in the exocrine cells of the pancreas, which are responsible for producing digestive enzymes. In non-metastatic cases, the cancer remains localized to the pancreas and nearby tissues, without spreading to distant parts of the body. Borderline resectable pancreatic cancer refers to tumors that are at the edge of being surgically removable, involving nearby blood vessels to a limited extent. The disease can affect the body’s ability to produce digestive enzymes and regulate blood sugar levels.

Trial ID:

2024-516260-29-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study comparing FOLFIRINOX versus gemcitabine-based chemoradiotherapy in patients with resectable or borderline resectable pancreatic cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?