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Study on Treating Stomach Cancer with Peritoneal Spread Using Docetaxel and Oxaliplatin in Patients with Limited Peritoneal Carcinomatosis

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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 treating patients with stomach cancer that has spread to the lining of the abdomen, a condition known as peritoneal dissemination. The study will explore the effectiveness of a treatment approach that combines surgery to remove cancerous tissue, known as cytoreductive surgery, with a special type of chemotherapy called hyperthermic intraperitoneal chemotherapy (HIPEC). This chemotherapy involves heating the chemotherapy drugs and delivering them directly into the abdominal cavity to target cancer cells more effectively.

The trial will compare this new treatment method to the current standard treatment, which is systemic palliative chemotherapy. Two chemotherapy drugs will be used in the study: docetaxel, marketed as TAXOTERE, and oxaliplatin, marketed as Oxaliplatine Accord. These drugs are administered as a solution for infusion, meaning they are given directly into the bloodstream through a vein.

The main goal of the study is to see if the new treatment method can improve the overall survival of patients compared to the standard treatment. Participants will undergo the treatment and be monitored for their response to the therapy, any side effects, and their quality of life. The study will also look at how the drugs are processed in the body and their ability to penetrate cancerous tissues. The trial is expected to continue until December 2025.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

    A biopsy is required to confirm the presence of primary adenocarcinoma or undifferentiated carcinoma of the stomach. Tumors at the junction of the esophagus and stomach are included if the majority of the tumor is in the stomach.

    A physical examination and laboratory tests are performed to ensure adequate bone marrow, liver, and kidney function.

  2. Step 2

    Pre-treatment evaluation

    A pre-treatment evaluation is conducted to assess the extent of peritoneal carcinomatosis, which is the spread of cancer within the abdominal cavity. This is confirmed through laparoscopy or laparotomy.

    The evaluation also includes a review of previous systemic chemotherapy treatments to ensure there has been no disease progression.

  3. Step 3

    Surgical intervention

    Eligible patients undergo a surgical procedure called gastrectomy, which involves the removal of part or all of the stomach.

    Cytoreductive surgery is performed to remove visible tumors within the abdominal cavity.

  4. Step 4

    Hyperthermic intraperitoneal chemotherapy (HIPEC)

    Following surgery, hyperthermic intraperitoneal chemotherapy (HIPEC) is administered. This involves the direct application of heated chemotherapy drugs into the abdominal cavity.

    The drugs used are docetaxel and oxaliplatin, both administered as a solution for infusion.

  5. Step 5

    Post-treatment monitoring

    After the HIPEC procedure, patients are monitored for treatment-related toxicity and overall health status.

    Regular follow-up visits are scheduled to assess progression-free survival and overall survival.

  6. Step 6

    Study completion

    The study is estimated to conclude by December 1, 2025.

    Final assessments will be conducted to evaluate the primary endpoint of overall survival and secondary endpoints such as quality of life and treatment-related costs.

Who can join the trial?

16 criteria

  • Must be **18 years or older**.
  • Must have **signed informed consent**, which means you agree to participate after understanding the study.
  • Must have a **biopsy-proven primary adenocarcinoma** (a type of cancer) of the stomach. This includes tumors at the junction of the esophagus and stomach, as long as most of the tumor is in the stomach and the planned surgery is to remove part of the stomach, not the esophagus.
  • Must have a **cT3-cT4 tumor**, which is a classification indicating the size and extent of the tumor, and it should be considered removable by surgery.
  • Must have **limited peritoneal carcinomatosis** (cancer spread in the abdominal lining) with a **PCI score less than 7**, or **tumor-positive peritoneal cytology** (cancer cells found in the abdominal fluid), confirmed by a procedure called laparoscopy or laparotomy and proven by a lab test.
  • Must have been treated with **systemic chemotherapy**, with the last treatment ending within **8 weeks** before joining the study.
  • Must not have any **disease progression** during the chemotherapy treatment before joining the study.
  • Must have a **WHO performance status of 0-2**, which means you are fully active or have some limitations but can still take care of yourself.
  • Must have **adequate bone marrow, liver, and kidney function**. This includes specific blood test results:
    • White blood cell count greater than 3.0 x 109/L
    • Platelet count of at least 100 x 109/L
    • Serum bilirubin (a liver function test) less than or equal to 1.5 times the upper limit of normal (ULN)
    • ALAT and ASAT (liver enzymes) less than or equal to 2.5 times the ULN
    • Creatinine clearance (a kidney function test) of at least 50 ml/min
    • For female patients who are not sterilized or in menopause:
      • Must have a **negative pregnancy test**.
      • Must not be **breastfeeding** or planning to become pregnant.
      • Must use **reliable contraceptive methods**.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the medications used in the study.
  • Patients who have a history of other types of cancer that could affect the study results.
  • Patients who have infections that are not well controlled.
  • Patients who have had major surgery recently.
  • Patients who have certain heart conditions that could pose a risk during the study.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Cytoreductive Surgery

    is a procedure aimed at removing as much of the cancerous tissue as possible from the peritoneal cavity. This surgery is used to reduce the number of cancer cells and improve the effectiveness of other treatments.

  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

    is a treatment that involves heating chemotherapy drugs and delivering them directly into the abdominal cavity. This method allows for higher concentrations of the drug to be in contact with the cancer cells, potentially increasing the effectiveness of the treatment.

  • Systemic Palliative Chemotherapy

    is a treatment that uses drugs to kill cancer cells throughout the body. It is considered the standard treatment for patients with advanced gastric cancer and is used to relieve symptoms and improve quality of life.

What is already known about the treatment

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) – This treatment is administered directly into the abdominal cavity after surgical removal of visible tumors, using heated chemotherapy drugs. It is currently being studied in clinical trials for its effectiveness in treating peritoneal dissemination in stomach cancer patients. The main therapeutic indication is to improve survival rates in patients with gastric cancer that has spread to the peritoneum. HIPEC works by delivering high concentrations of chemotherapy directly to cancer cells in the abdomen, enhancing drug absorption and effectiveness due to the heat. It is classified under regional chemotherapy treatments, specifically targeting cancer cells in the abdominal area.

Investigated diseases

Peritoneal Carcinomatosis in Gastric Cancer – This condition occurs when cancer cells from the stomach spread to the lining of the abdominal cavity, known as the peritoneum. It is a form of metastasis that can happen in advanced stages of gastric cancer. The spread of cancer cells to the peritoneum can lead to the formation of multiple small tumors on the peritoneal surface. This can cause symptoms such as abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary, with some patients experiencing a gradual increase in symptoms. The condition is often associated with a more complex disease course due to the involvement of the abdominal cavity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510159-53-01Protocol codeNL56123.031.15Estimated enrolment226 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).