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Study Comparing Short-Course and Long-Course Chemotherapy with mFOLFIRINOX or PAXG for Patients with Stage I-III Pancreatic Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called pancreatic ductal adenocarcinoma, which affects the pancreas. The study is comparing two different chemotherapy treatments to see which is more effective. The treatments being tested are called mFOLFIRINOX and PAXG. These treatments involve a combination of medications that are given to patients before surgery to help shrink the cancer. The medications used in these treatments include Abraxane (paclitaxel albumin-bound), Leucovorin (calcium folinate pentahydrate), Gemcitabine, Capecitabine, Irinotecan (irinotecan hydrochloride trihydrate), Oxaliplatin, Cisplatin, and Fluorouracil.

The purpose of the study is to compare the effectiveness of the PAXG treatment to the mFOLFIRINOX treatment in terms of how long patients remain free from cancer progression. Participants in the study will receive either the short-course or long-course version of these treatments before undergoing surgery. The study will monitor the patients over a period of time to assess various outcomes, such as the response of the cancer to the treatment, the rate at which the cancer can be surgically removed, and the overall health and well-being of the patients during and after the treatment.

Throughout the study, patients will receive their treatments through intravenous infusions, which means the medication is delivered directly into the bloodstream through a vein. The study aims to provide valuable information on which treatment approach is more beneficial for patients with pancreatic ductal adenocarcinoma, potentially leading to improved treatment strategies in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two treatment groups: the mFOLFIRINOX group or the PAXG group. This assignment is done to compare the effectiveness of these two chemotherapy regimens for treating pancreatic ductal adenocarcinoma.

  2. Step 2

    Treatment with mFOLFIRINOX

    If assigned to the mFOLFIRINOX group, the patient will receive a combination of medications administered intravenously. These medications include oxaliplatin, irinotecan hydrochloride trihydrate, fluorouracil, and calcium folinate pentahydrate. The treatment is given in cycles, with each cycle lasting two weeks. The exact dosage and frequency will be determined by the medical team based on the patient's condition.

  3. Step 3

    Treatment with PAXG

    If assigned to the PAXG group, the patient will receive a combination of medications that include paclitaxel albumin-bound, gemcitabine, cisplatin, and capecitabine. The first three medications are administered intravenously, while capecitabine is taken orally. The treatment is structured in cycles, with each cycle lasting three weeks. The medical team will provide specific instructions regarding dosage and frequency.

  4. Step 4

    Monitoring and assessments

    Throughout the treatment period, the patient will undergo regular monitoring and assessments to evaluate the response to the therapy. This includes imaging tests to measure tumor size and blood tests to check for any side effects. The medical team will use these assessments to adjust the treatment plan as necessary.

  5. Step 5

    Surgery evaluation

    After completing the chemotherapy cycles, the patient's eligibility for surgery will be evaluated. This evaluation will determine if the tumor can be surgically removed. The decision will be based on the size and location of the tumor, as well as the patient's overall health.

  6. Step 6

    Follow-up

    Following the treatment and any potential surgery, the patient will enter a follow-up phase. During this time, the patient's health and any signs of cancer recurrence will be closely monitored. Regular check-ups and tests will be scheduled to ensure the patient's well-being.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of **pancreatic ductal adenocarcinoma**. This means the type of cancer has been identified through tests.
  • Women must not be pregnant or breastfeeding.
  • If you can have children, you must agree to use two reliable methods of birth control during the study and for at least 6 months after. This applies to both men and women.
  • You must receive information about the study and sign a consent form to show you agree to participate.
  • Your cancer must be at **clinical stage I-III**. This refers to the size and spread of the cancer.
  • The cancer must be **resectable** or **borderline resectable**. This means it can be removed by surgery or is close to being removable.
  • You must have a **Karnofsky Performance Status** greater than 60%. This is a score that measures your ability to perform daily activities.
  • You must be between 18 and 75 years old.
  • You must have adequate **bone marrow function**. This means your blood cell levels are within a certain range.
  • You must have adequate **kidney function**. This is determined by a blood test measuring creatinine levels.
  • You must have adequate **liver function**. This is determined by blood tests measuring ALT, AST, and bilirubin levels.
  • You must not have received any previous treatment for pancreatic cancer, such as chemotherapy, radiotherapy, or surgery.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than pancreatic ductal adenocarcinoma cannot participate. This is a type of cancer that starts in the ducts of the pancreas.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • mFOLFIRINOX

    is a combination chemotherapy regimen used to treat pancreatic cancer. It includes several drugs that work together to stop the growth of cancer cells. This regimen is often used before surgery to shrink the tumor and make it easier to remove.

  • PAXG

    is another chemotherapy regimen used for treating pancreatic cancer. It combines different drugs to target and kill cancer cells. Like mFOLFIRINOX, it is used before surgery to reduce the size of the tumor and improve surgical outcomes.

What is already known about the treatment

  • mFOLFIRINOX

    This medication is administered intravenously and is used in the treatment of pancreatic ductal adenocarcinoma. It is currently being studied in clinical trials to determine its effectiveness compared to other chemotherapy regimens. The main therapeutic indication is for patients with stage I-III pancreatic cancer. At the molecular level, mFOLFIRINOX works by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and division. It is classified as a combination chemotherapy regimen.

  • PAXG

    This medication is also administered intravenously and is being evaluated for its use in treating pancreatic ductal adenocarcinoma. It is part of ongoing clinical research to assess its efficacy against other treatment options. The primary therapeutic indication is for patients with stage I-III pancreatic cancer. PAXG functions by targeting and disrupting the cellular processes necessary for cancer cell survival and proliferation. It falls under the category of combination chemotherapy regimens.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is known for its aggressive nature and tendency to spread quickly to nearby organs. The disease often progresses silently, with symptoms appearing only in advanced stages. Common symptoms may include abdominal pain, weight loss, and jaundice. As the cancer grows, it can obstruct the bile duct, leading to further complications. The progression of the disease is typically monitored through imaging studies and tumor marker levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519031-42-00Protocol codePACT-21/CASSANDRAEstimated enrolment261 patientsSponsorAssociazione Italiana Per Lo Studio Del Pancreas

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