Study of Gemcitabine with Paclitaxel versus Standard Chemotherapy Combination for Patients with Borderline Resectable Pancreatic Cancer Based on Gene Analysis

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What is this study about?

This study focuses on patients with borderline resectable pancreatic adenocarcinoma, which is a type of pancreatic cancer that may be surgically removed after initial treatment. The study aims to evaluate the effectiveness of different chemotherapy combinations based on specific genetic markers in the tumor tissue before surgery.

The study uses several chemotherapy medications including gemcitabine, paclitaxel, fluorouracil, irinotecan, oxaliplatin, and folinic acid. Some patients will receive a combination of gemcitabine and paclitaxel, while others will receive a combination of the other medications. The choice of treatment will be based on specific genetic patterns found in the tumor tissue.

The treatment involves receiving chemotherapy for 4 months before surgery. After surgery, patients will continue to be monitored to evaluate how well the treatment worked. Throughout the study, doctors will track various measures of treatment success, including whether the cancer returns and how long patients live without the disease getting worse.

1 Initial evaluation

A medical team will confirm your diagnosis of borderline resectable pancreatic cancer through CT scan evaluation

Your tumor tissue sample will be analyzed to determine its specific characteristics

Basic health tests will be performed to check your organ function, including blood tests

2 Treatment assignment

Based on your tumor’s characteristics, you will receive one of two treatment options:

Option 1: Gemcitabine with Paclitaxel administered through intravenous infusion

Option 2: mFOLFIRINOX treatment (combination of fluorouracil, folinic acid, irinotecan, and oxaliplatin) administered through intravenous infusion

3 Initial treatment phase

You will receive treatment for 4 months before potential surgery

Regular evaluations will monitor your response to treatment

Blood tests and imaging scans will be performed to track your progress

Side effects will be monitored and documented before each treatment cycle

4 Surgical evaluation

After the initial 4-month treatment period, your medical team will evaluate if surgery is possible

If surgery is appropriate, the procedure will be scheduled

5 Follow-up care

Regular check-ups will continue to monitor your health

Quality of life assessments will be conducted using standard questionnaires

Your progress will be tracked until the study end date in April 2031

Who Can Join the Study?

  • Age between 18 and 80 years old (for patients 75-80, a geriatric evaluation is required)
  • Diagnosed with borderline resectable pancreatic ductal adenocarcinoma, confirmed by CT scan and reviewed by a medical team
  • Must have a tumor tissue sample available with more than 10% tumor cells
  • No previous cancer treatments (chemotherapy or radiation) for pancreatic cancer
  • Good overall physical condition (WHO Performance Status of 0 or 1, meaning able to perform daily activities)
  • Adequate organ function, including:
    • Liver tests (AST and ALT) less than 3.5 times normal limits
    • Bilirubin less than 3 times normal limits
    • Albumin above 30 g/L
    • Hemoglobin above 9.0 g/dl
    • White blood cells (neutrophils) above 1.5 G/L
    • Platelets above 100 G/L
    • Kidney function (creatinine clearance) above 50 mL/min
  • Must use contraception during treatment:
    • Women: during treatment and 15 months after
    • Men: during treatment and 12 months after
  • Must be able to follow study requirements, including scheduled visits and examinations
  • Must provide written informed consent before starting the study

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous treatment with chemotherapy or radiation therapy for pancreatic cancer
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Significant heart problems or uncontrolled heart disease
  • Active or uncontrolled infections
  • Known allergies to Gemcitabine or Nab-Paclitaxel (chemotherapy medications used in the study)
  • Pregnancy or breastfeeding
  • Severe kidney or liver dysfunction
  • Participation in other clinical trials within 30 days before starting this study
  • Psychological, family, sociological, or geographical conditions that would prevent proper follow-up and compliance with the study protocol
  • Any other serious medical condition that could interfere with safe participation in the trial
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital Beaujon Clichy France
HIA Sainte Anne Toulon France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.10.2025

Trial locations

Gemcitabine is a chemotherapy medication used to treat various types of cancer, including pancreatic cancer. It works by interfering with cancer cell growth and division, helping to slow or stop the spread of cancer cells.

Nab-paclitaxel (also known as albumin-bound paclitaxel) is a chemotherapy drug that targets and kills cancer cells by preventing them from dividing. It is bound to a protein called albumin, which helps deliver the medication more effectively to cancer cells.

FOLFIRINOX is a combination chemotherapy treatment that contains multiple medications working together to fight cancer. This treatment combines different drugs that work in various ways to kill cancer cells and prevent them from growing and spreading.

Pancreatic Ductal Adenocarcinoma – A type of cancer that begins in the cells lining the ducts of the pancreas. The disease typically starts in the pancreatic ducts and can gradually spread to nearby tissues. In its borderline resectable form, the tumor has limited involvement with nearby blood vessels but may still be surgically removable. The condition often develops slowly at first, potentially affecting the pancreas’s ability to produce digestive enzymes and hormones. As the disease progresses, it can affect surrounding tissues and organs.

Borderline Resectable Pancreatic Cancer – A specific classification of pancreatic cancer where the tumor shows limited involvement with nearby blood vessels. This condition represents an intermediate stage between clearly resectable and unresectable pancreatic cancer. The tumor touches or wraps around nearby blood vessels but does so in a way that might still allow for surgical removal. The disease affects the pancreas and its immediate surrounding structures.

Trial ID:
2024-519753-11-00
Protocol code:
PRODIGE 104 A
Trial Phase:
Therapeutic exploratory (Phase II)

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