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Study on the Effect of Hyperthermic Intraperitoneal Chemotherapy with Cisplatin for Stage III Ovarian Cancer Patients Undergoing Surgery

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 the effects of a treatment for patients with stage III epithelial ovarian cancer. The treatment involves a surgical procedure called primary cytoreductive surgery, which aims to remove as much of the cancer as possible. In some cases, this surgery is combined with a special type of chemotherapy known as hyperthermic intraperitoneal chemotherapy (HIPEC). This study aims to understand how adding HIPEC to the surgery might affect the overall survival of patients.

The trial involves several medications that are used during the treatment process. These include Paclitaxel Eugia, a solution for infusion that helps stop cancer cells from growing, and Sodium Thiosulfate, which is used to reduce side effects. Another medication used is Avastin, which works by preventing the growth of blood vessels that supply the tumor. Additionally, Cisplatin and Carboplatin are used, both of which are types of chemotherapy that help kill cancer cells. These medications are administered through an intravenous infusion, meaning they are given directly into a vein.

Participants in the study will undergo the primary cytoreductive surgery, and some will receive the additional HIPEC treatment. The study will monitor the patients over time to see how the treatments affect their survival and if the cancer returns. The goal is to determine if the combination of surgery and HIPEC provides a better outcome for patients with stage III epithelial ovarian cancer compared to surgery alone. The study will also look at the time it takes for patients to need further cancer treatment and any side effects experienced during the treatment period.

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 study

    Upon joining the study, the patient must provide a signed and written informed consent.

    Eligibility is confirmed based on specific criteria, including age, diagnosis, and overall health status.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's health status and confirm eligibility.

    This includes completing a baseline health-outcome questionnaire.

  3. Step 3

    Randomization

    The patient is randomly assigned to one of the study groups.

    This process may occur during surgery if histological proof is obtained from intraoperative frozen section material.

  4. Step 4

    Surgery

    The patient undergoes primary cytoreductive surgery, which aims to remove as much of the cancer as possible.

    The surgery may include hyperthermic intraperitoneal chemotherapy (HIPEC) depending on the randomization.

  5. Step 5

    Chemotherapy

    Chemotherapy is administered using a combination of medications, including paclitaxel, sodium thiosulfate, bevacizumab, cisplatin, and carboplatin.

    These medications are given through intravenous infusion, with cisplatin also administered intraperitoneally.

    The specific dosage, frequency, and duration of administration are determined by the study protocol.

  6. Step 6

    Follow-up

    Regular follow-up appointments are scheduled to monitor the patient's health and response to treatment.

    The primary endpoint is overall survival, while secondary endpoints include recurrence-free survival and time to first subsequent anticancer treatment.

  7. Step 7

    End of study

    The study is estimated to conclude by July 2025.

    Final assessments are conducted to evaluate the outcomes and any long-term effects of the treatment.

Who can join the trial?

9 criteria

  • You must provide a signed and written informed consent, which means you agree to participate after understanding the study details.
  • You need to be at least 18 years old.
  • You should have a confirmed diagnosis of FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer. This means the cancer is in a specific stage and type, and you have had surgery to remove as much of it as possible, leaving no more than 2.5 mm of cancer behind.
  • You must be fit for major surgery, with a WHO performance status of 0-2. This is a measure of your general well-being and ability to carry out daily activities.
  • Your bone marrow function should be adequate, meaning your blood levels are within a certain range: hemoglobin level greater than 5.5 mmol/L, leukocytes greater than 3 x 109/L, and platelets greater than 100 x 109/L.
  • Your liver function should be adequate, with ALT, AST, and bilirubin levels less than 2.5 times the upper limit of normal. If you have Gilbert's disease, your unconjugated bilirubin should be less than 5 times the upper limit of normal.
  • Your kidney function should be adequate, with a creatinine clearance of at least 60 ml/min. This is a measure of how well your kidneys are working.
  • You need to complete a baseline health-outcome questionnaire before being randomly assigned to a treatment group.
  • You should be able to understand the patient information and questionnaires provided during the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have **FIGO stage III ovarian cancer**. This is a classification used to describe the extent of ovarian cancer.
  • Patients who are not eligible for **primary cytoreductive surgery**. This is a surgery aimed at removing as much of the cancer as possible.
  • Patients who have residual disease larger than 2.5 mm after surgery. **Residual disease** refers to cancer that remains after treatment.
  • Patients who are male, as the study is only for female subjects.
  • Patients who are part of a vulnerable population, which means groups that may need special protection or care.
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Investigated drugs

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a treatment used in this clinical trial for patients with stage III epithelial ovarian cancer. During this procedure, after the surgical removal of visible tumors, a heated chemotherapy solution is delivered directly into the abdominal cavity. The heat helps to enhance the effectiveness of the chemotherapy, aiming to kill any remaining cancer cells and improve overall survival rates. This therapy is being tested to see if it provides additional benefits when combined with primary cytoreductive surgery.

What is already known about the treatment

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) – This treatment is administered directly into the abdominal cavity during surgery, using heated chemotherapy drugs. It is currently being studied in clinical trials for its effectiveness in treating stage III ovarian cancer, particularly in patients undergoing primary cytoreductive surgery. The main therapeutic indication is to improve overall survival in these patients. 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 as a localized chemotherapy treatment.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms can include abdominal bloating, pelvic pain, and changes in bowel habits. The disease is classified into stages, with FIGO stage III indicating that the cancer has spread within the pelvis or abdomen. Treatment often involves surgery and chemotherapy, but the specific approach can vary based on the stage and characteristics of the cancer. The progression of ovarian cancer can be influenced by factors such as the type of cancer cells and the patient's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509049-11-00Protocol codeOVHIPEC-2Estimated enrolment538 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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