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Study on FOLFOX and Docetaxel for Patients with Advanced or Metastatic Stomach and Esophagus Cancer

Verified siteRegistered drugNo placebo
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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 oesophago-gastric adenocarcinoma, which affects the stomach and the area where the esophagus meets the stomach. The trial is exploring the effectiveness of a chemotherapy treatment called FOLFOX, which includes the medications fluorouracil, calcium levofolinate, and oxaliplatin. Additionally, the study is evaluating whether adding another medication, anhydrous docetaxel, to this treatment regimen, referred to as TFOX, can improve outcomes for patients.

The purpose of the study is to determine if these treatments can help patients live longer without their cancer getting worse. Participants in the trial will receive either the FOLFOX treatment or the TFOX treatment. Some participants may receive a placebo. The study will last for a period of up to 24 months, during which time the effects of the treatments will be monitored and compared.

By participating in this trial, researchers hope to gather important information about the potential benefits of adding anhydrous docetaxel to the standard FOLFOX treatment for patients with locally advanced or metastatic oesophago-gastric adenocarcinoma. The ultimate goal is to improve the quality of life and survival rates for individuals affected by this type of cancer.

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, eligibility is confirmed based on specific criteria such as age, medical condition, and previous treatments.

    The study focuses on patients with locally advanced or metastatic oesophago-gastric adenocarcinoma.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either FOLFOX or TFOX chemotherapy regimens.

    FOLFOX includes fluorouracil, calcium levofolinate, and oxaliplatin.

    TFOX includes the FOLFOX regimen with the addition of anhydrous docetaxel.

  3. Step 3

    Chemotherapy administration

    Chemotherapy is administered through intravenous methods.

    Anhydrous docetaxel is given via intravenous infusion.

    Fluorouracil is administered as an intravenous bolus and perfusion.

    Oxaliplatin is given through intravenous perfusion.

    Calcium levofolinate is administered intravenously.

  4. Step 4

    Treatment cycle

    The treatment is given in cycles, with specific dosages and schedules determined by the study protocol.

    The duration and frequency of each cycle depend on the individual treatment plan.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and manage any side effects.

    Progression-free survival is evaluated 12 months after the last randomization.

  6. Step 6

    Study completion

    The study is estimated to conclude by February 28, 2025.

    Overall survival and other outcomes are assessed at the end of the study.

Who can join the trial?

8 criteria

  • The patient must have a type of cancer called adenocarcinoma in the stomach or where the stomach meets the esophagus. This must be confirmed by a test called a histology, which examines tissue under a microscope.
  • The cancer must be HER2 negative. HER2 is a protein that can affect the growth of cancer cells. A test called IHC (Immunohistochemistry) is used to check HER2 levels, and it should not be 3+ or 2+ with a positive FISH (Fluorescence In Situ Hybridization) test.
  • The cancer must be either metastatic (spread to other parts of the body) or unresectable (cannot be removed by surgery) and locally advanced.
  • The disease must be measurable according to specific guidelines called RECIST v1.1, which means there should be at least one area of cancer that can be measured.
  • The patient should not have had any major surgery in the 4 weeks before joining the study.
  • The patient must be eligible for a first round of chemotherapy using drugs called 5FU, folinic acid, and oxaliplatin (known as FOLFOX), with or without another drug called docetaxel (known as TFOX).
  • The patient must have a WHO performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must be 18 years of age or older.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with allergies to the study medication or its ingredients.
  • Patients who cannot follow the study procedures or instructions.
  • Patients with a history of certain types of cancer other than the one being studied.
  • Patients with severe liver or kidney problems.
  • Patients with uncontrolled infections.
  • Patients with certain heart conditions.
  • Patients who are unable to provide informed consent.
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Investigated drugs

  • FOLFOX

    is a combination chemotherapy regimen used to treat certain types of cancer, including oesophago-gastric adenocarcinoma. It typically includes a mix of medications that work together to stop cancer cells from growing and dividing. The main components of FOLFOX are a platinum-based drug and a type of chemotherapy called fluoropyrimidine.

  • DOCETAXEL

    is a chemotherapy medication that is used to treat various types of cancer. In this trial, it is being evaluated in combination with FOLFOX to see if it improves treatment outcomes for patients with locally advanced or metastatic oesophago-gastric adenocarcinoma. Docetaxel works by interfering with the growth and spread of cancer cells.

What is already known about the treatment

Docetaxel – Docetaxel is administered intravenously, typically as part of a chemotherapy regimen. It is currently used in clinical settings and extensively documented in medical literature for its role in cancer treatment. The main therapeutic indication for Docetaxel in this trial is for treating locally advanced or metastatic oesogastric adenocarcinoma. At the molecular level, Docetaxel works by inhibiting cell division, specifically by stabilizing microtubules and preventing their disassembly, which is crucial for cell division. It is classified as a taxane, a type of antineoplastic agent used in chemotherapy.

Investigated diseases

Locally advanced or metastatic oesogastric adenocarcinoma – This is a type of cancer that occurs in the glandular cells lining the stomach and esophagus. It is considered locally advanced when it has spread to nearby tissues or lymph nodes but not to distant parts of the body. When it becomes metastatic, it means the cancer has spread to other organs or distant lymph nodes. The disease often progresses by invading surrounding tissues and can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. As the cancer advances, it may cause more severe symptoms and complications due to its spread. The progression of this disease can vary, but it typically involves a gradual worsening of symptoms as the cancer grows and spreads.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515221-29-00Protocol codePRODIGE 51 - GASTFOXEstimated enrolment507 patientsSponsorFondation Franc.Cancerologie Digestive

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