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Study on the Effect of Calcium Folinate, Gemcitabine, and Fluorouracil in Patients with Advanced 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 treatments for advanced pancreatic cancer, specifically in patients with borderline and locally advanced stages of the disease. The trial aims to determine the best duration of preoperative chemotherapy to improve survival rates. The treatments being tested include several chemotherapy drugs: Calcium Folinate, Gemcitabine, Fluorouracil, Irinotecan Hydrochloride Trihydrate, Oxaliplatin, and paclitaxel. These medications are administered through intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to assess how long patients should receive chemotherapy before undergoing surgery to remove the cancer. Participants will be randomly assigned to receive either a standard or prolonged course of chemotherapy. The study will monitor patients over a period of time to see how the different treatment durations affect their overall survival and progression-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse.

Throughout the study, patients will receive regular treatments and follow-up care to monitor their health and the effectiveness of the chemotherapy. The trial will help determine the most effective treatment plan for patients with advanced pancreatic cancer, potentially leading to improved outcomes and longer survival rates. The study is expected to continue until the end of 2032, with ongoing assessments of patient health and treatment responses.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, procedures, and potential risks and benefits. You will be required to provide written consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of borderline or locally advanced pancreatic cancer and ensuring you meet other criteria such as age and general health status.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups: one receiving standard chemotherapy and the other receiving prolonged chemotherapy. This process is random to ensure fairness and objectivity in the study.

  4. Step 4

    Chemotherapy treatment

    You will receive chemotherapy through intravenous infusion. The medications used may include calcium folinate, gemcitabine, fluorouracil, irinotecan hydrochloride trihydrate, oxaliplatin, and paclitaxel. The specific dosage and frequency will be determined by the study protocol and your healthcare team.

  5. Step 5

    Monitoring and follow-up

    Throughout the treatment, regular monitoring will be conducted to assess your response to the chemotherapy and to manage any side effects. This may involve blood tests, imaging studies, and physical examinations.

  6. Step 6

    Surgery evaluation

    After completing the chemotherapy phase, your eligibility for surgery will be evaluated. This decision will be based on the response of your cancer to the treatment and your overall health status.

  7. Step 7

    Post-treatment follow-up

    Following the completion of the trial treatment, you will continue to be monitored for your overall health and cancer status. This follow-up period is crucial for assessing the long-term effects of the treatment and your survival outcomes.

Who can join the trial?

7 criteria

  • Must have been diagnosed with borderline or locally advanced pancreatic adenocarcinoma according to specific medical guidelines.
  • The diagnosis must be confirmed through a procedure called histology (examining tissue under a microscope) or cytology (examining cells).
  • The cancer stage should be T1-4, Nx, M0 according to a specific cancer staging system (AJCC 8th edition), which means the cancer has not spread to distant parts of the body.
  • Must be 18 years of age or older.
  • Must have an ECOG performance status of 0-1, which means the patient is fully active or has some symptoms but does not require bed rest during the day.
  • Must be considered fit for the planned chemotherapy and surgery by the medical team.
  • Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides advanced pancreatic cancer cannot participate.
  • Patients who have had previous surgery for pancreatic cancer are not eligible.
  • Patients with severe heart problems cannot take part in the study.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients with severe liver disease cannot participate.
  • Patients with severe kidney disease are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with active infections that require treatment are excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with known allergies to the study medication cannot participate.
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Investigated drugs

{ "authorizedApplication.authorizedPartI.products.0": [ { "productName": "Gemcitabine", "description": "Gemcitabine is a type of chemotherapy drug that is used to treat various types of cancer, including pancreatic cancer. It works by slowing or stopping the growth of cancer cells." }, { "productName": "Nab-Paclitaxel", "description": "Nab-Paclitaxel is a chemotherapy medication used to treat pancreatic cancer. It helps to stop the growth of cancer cells by interfering with their ability to divide." }, { "productName": "FOLFIRINOX", "description": "FOLFIRINOX is a combination of four chemotherapy drugs used to treat pancreatic cancer. It is designed to attack cancer cells in different ways, making it a powerful treatment option." } ] } Gemcitabine is a type of chemotherapy drug that is used to treat various types of cancer, including pancreatic cancer. It works by slowing or stopping the growth of cancer cells. Nab-Paclitaxel is a chemotherapy medication used to treat pancreatic cancer. It helps to stop the growth of cancer cells by interfering with their ability to divide. FOLFIRINOX is a combination of four chemotherapy drugs used to treat pancreatic cancer. It is designed to attack cancer cells in different ways, making it a powerful treatment option.

What is already known about the treatment

  • Calcium folinate

    Calcium folinate, also known as leucovorin, is a medicine given as an infusion into a vein alongside certain chemotherapy drugs. It is a form of folinic acid, an active variant of the vitamin folate, and has been used for decades in cancer treatment. In regimens for pancreatic and bowel cancer it does not fight the tumour itself but strengthens the anticancer effect of fluorouracil by stabilising the complex that fluorouracil forms with its target enzyme in cancer cells. It is classified as a chemotherapy-modulating and protective (detoxifying) agent.

  • Gemcitabine

    Gemcitabine is a chemotherapy medicine administered as an intravenous infusion, usually once weekly in cycles. It has long been a standard treatment for pancreatic cancer and is also used in lung, bladder, breast and ovarian cancers. It mimics one of the natural building blocks of DNA; once built into the DNA of a dividing cancer cell it halts further DNA construction, so the cell cannot multiply and dies. It belongs to the antimetabolite group known as pyrimidine analogues.

  • Irinotecan

    Irinotecan is a chemotherapy medicine given as an infusion into a vein and is a key component of the FOLFIRINOX combination used for advanced pancreatic cancer, as well as a standard drug in bowel cancer. It is derived from a substance found in an Asian tree. It blocks the enzyme topoisomerase I, which cells need to relax their DNA while copying it; the blocked enzyme leaves breaks in the DNA, which kills rapidly dividing tumour cells. It is classified as a topoisomerase I inhibitor.

  • Oxaliplatin

    Oxaliplatin is a platinum-based chemotherapy medicine administered as an intravenous infusion and is another essential part of the FOLFIRINOX regimen for pancreatic cancer. It is also one of the standard drugs for bowel cancer. The platinum atom in the drug binds to the DNA of cancer cells and forms cross-links that block the copying and reading of genetic material, pushing the cells into programmed death. It belongs to the group of platinum compounds.

  • Paclitaxel

    Paclitaxel is a chemotherapy medicine given as an infusion into a vein, originally obtained from the yew tree. It is widely used in breast, ovarian and lung cancer, and in pancreatic cancer it is typically combined with gemcitabine. It binds to the microtubules, the internal scaffolding of cells, and prevents them from being taken apart, so dividing cancer cells become stuck in mid-division and die. It is classified as a taxane.

  • Fluorouracil

    Fluorouracil, often abbreviated 5-FU, is one of the oldest chemotherapy medicines and is given as an injection or prolonged infusion into a vein. It remains a backbone of treatment for cancers of the digestive system, including pancreatic and bowel cancer. It is a false version of a natural DNA and RNA building block: it blocks the enzyme thymidylate synthase and becomes incorporated into the genetic material of cancer cells, stopping them from growing and dividing. It belongs to the antimetabolite group of pyrimidine analogues.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – Pancreatic ductal adenocarcinoma is a type of cancer that originates in the ducts of the pancreas. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can form a tumor. As the disease progresses, the tumor may invade nearby tissues and organs, such as the stomach, liver, and intestines. The cancer can also spread to distant parts of the body through the lymphatic system or bloodstream. Symptoms often include abdominal pain, weight loss, and jaundice, which is a yellowing of the skin and eyes. The progression of the disease can lead to complications such as digestive issues and diabetes due to the pancreas's role in producing insulin and digestive enzymes.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502117-29-00Estimated enrolment754 patientsSponsorVaestra Goetalandsregionen

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