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Study on the Effectiveness of Hyperthermic Intraperitoneal Chemotherapy with Cisplatin and Sodium Thiosulfate for Ovarian Cancer Patients Undergoing Surgery

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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 method called hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. The study specifically looks at three types of ovarian cancer: epithelial ovarian cancer, fallopian tube ovarian cancer, and peritoneal ovarian cancer. The treatment being tested involves using a heated chemotherapy drug, cisplatin, which is administered directly into the abdominal cavity during surgery. Another drug, sodium thiosulfate, is also used in the study. The purpose of the study is to determine if this treatment can help patients live longer without the disease coming back.

Participants in the study will undergo one of two types of surgeries: Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS). These surgeries are performed to remove as much of the cancer as possible. After the surgery, some patients will receive the HIPEC treatment, while others will receive standard care without HIPEC. The study will compare the outcomes of these two groups to see if the HIPEC treatment is more effective. The study will also monitor the overall survival of patients and any side effects they may experience during the treatment.

The trial will follow participants over a period of time to assess their disease-free survival (DFS), which means the length of time they live without the cancer returning. Researchers will also evaluate the overall quality of life of the participants using questionnaires. The study aims to provide valuable information on whether adding HIPEC to standard surgical treatment can improve outcomes for patients with ovarian cancer.

The research process

The trial runs in 8 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, including age, health status, and medical history.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Surgery preparation

    Preparation for either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS) is necessary.

    Pre-surgery assessments include blood tests and imaging to evaluate health status and surgical readiness.

  3. Step 3

    Surgery

    Surgery involves removing as much of the tumor as possible.

    During surgery, criteria such as residual disease and blood loss are assessed to confirm continued eligibility.

  4. Step 4

    Hyperthermic intraperitoneal chemotherapy (HIPEC)

    HIPEC may be administered during surgery, involving heated chemotherapy directly applied to the abdominal cavity.

    The chemotherapy drugs used are sodium thiosulfate and cisplatin, delivered through intravenous or intraperitoneal routes.

  5. Step 5

    Post-surgery recovery

    Recovery from surgery is monitored, focusing on healing and managing any immediate side effects.

    Regular follow-up visits are scheduled to assess recovery progress and address any complications.

  6. Step 6

    Adjuvant chemotherapy

    Adjuvant chemotherapy may be administered following surgery to target any remaining cancer cells.

    The timing and type of chemotherapy depend on individual treatment plans and may include additional medications like bevacizumab.

  7. Step 7

    Follow-up and monitoring

    Regular follow-up visits are conducted to monitor health status and detect any signs of cancer recurrence.

    Quality of life assessments and adverse event monitoring are part of ongoing evaluations.

  8. Step 8

    End of study participation

    Participation concludes after the final follow-up visit, which assesses overall health and treatment outcomes.

    Data collected during the study contribute to understanding the effectiveness of the treatment.

Who can join the trial?

16 criteria

  • Age between 18 and 76 years.
  • Willing and able to follow the study plan, including treatment, visits, and exams.
  • Signed a written consent form approved by an ethics board.
  • Covered by the French or Belgian "Social Security" system.
  • During surgery, no visible leftover cancer or very small leftover cancer (less than 2.5 mm).
  • During surgery, blood loss should be less than 2.5 liters.
  • During surgery, no more than two parts of the digestive system removed, except for the appendix.
  • During surgery, urine output should be maintained, meaning no low urine output or no urine output.
  • Confirmed diagnosis of certain types of ovarian, fallopian tube, or peritoneal cancer.
  • Cancer stage III according to FIGO, a system used to describe the extent of cancer.
  • Eligible for specific types of surgery and chemotherapy, with or without additional targeted therapy.
  • WHO Performance Status of 2 or less, which measures general well-being and ability to perform daily activities.
  • Physical status score ASA2 of 2 or less, or ASA of 3 if related to a high body mass index (BMI) or fluid in the abdomen due to cancer.
  • Good bone marrow and kidney function, shown by specific blood tests done within 7 days before surgery.
  • Negative pregnancy test within 7 days before surgery for women who can have children. If not menopausal and no uterus removal planned, agree to use effective birth control during treatment and for at least 6 months after.
  • No reasons preventing the use of study medications, such as cisplatin and other chemotherapy drugs.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with epithelial ovarian cancer, fallopian tube ovarian cancer, or peritoneal ovarian cancer cannot participate. These are specific types of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen.
  • Only female patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a treatment used in this trial for ovarian cancer. It involves delivering heated chemotherapy directly into the abdominal cavity during surgery. The heat helps to enhance the effectiveness of the chemotherapy, aiming to kill any remaining cancer cells after the visible tumors have been removed. This method is being evaluated to see if it improves the time patients remain free from the disease compared to standard surgical care alone.

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 ovarian cancer, specifically epithelial, fallopian tube, and peritoneal types. The main therapeutic indication is to improve disease-free survival in patients undergoing primary or interval debulking surgery. 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

  • Epithelial Ovarian Cancer

    This type of cancer originates in the cells on the surface of the ovary. It often goes undetected until it has spread within the pelvis and abdomen. As the disease progresses, it may cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The cancer can spread to nearby tissues and organs, making it more challenging to manage over time.

  • Fallopian Tube Ovarian Cancer

    This cancer begins in the fallopian tubes, which connect the ovaries to the uterus. It shares many characteristics with epithelial ovarian cancer, including similar symptoms and progression patterns. The disease may spread to the ovaries and other parts of the reproductive system. As it advances, it can lead to abdominal discomfort and other systemic symptoms.

  • Peritoneal Ovarian Cancer

    This cancer affects the peritoneum, a thin layer of tissue lining the abdomen. It is closely related to epithelial ovarian cancer and often presents with similar symptoms. The disease can spread throughout the abdominal cavity, affecting various organs. As it progresses, it may cause abdominal swelling, pain, and digestive issues.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514706-31-01Estimated enrolment352 patientsSponsorCentre Oscar Lambret

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).