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Study on the Effectiveness and Safety of Cisplatin and Paclitaxel in Advanced Ovarian Cancer Patients After 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 focuses on studying the treatment of ovarian cancer, specifically in its advanced stages. The study involves a combined treatment approach using two medications: Paclitaxel and Cisplatin. These medications are administered as a solution through a process called infusion, which means they are delivered directly into the bloodstream through a vein. The purpose of the study is to investigate whether this combined treatment is feasible, effective, and safe for patients who have undergone surgery to remove as much of the cancer as possible.

The study will involve administering chemotherapy in two ways: directly into the abdomen (intraperitoneal) and through the bloodstream (systemic). This approach is known as bidirectional chemotherapy. The study will monitor the safety of this treatment by observing any complications or side effects that may occur. Additionally, the effectiveness of the treatment will be assessed by measuring how long patients live without the cancer returning and their overall survival over one, three, and five years.

Participants in the study will receive the treatment over a period of four cycles, with each cycle lasting a specific amount of time. The study will also evaluate the quality of life of patients after completing the treatment using specific questionnaires. The goal is to gather information that could help improve treatment options for patients with advanced ovarian cancer in the future.

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, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes confirming your age, medical history, and current health status. Tests will be performed to check your liver, kidney, and bone marrow function, as well as a pregnancy test if applicable.

  3. Step 3

    Surgery

    You will undergo a surgical procedure called cytoreduction, which aims to remove as much of the ovarian cancer as possible. This step is crucial for the subsequent chemotherapy treatment.

  4. Step 4

    Chemotherapy treatment

    After surgery, you will receive a combined chemotherapy treatment. This involves the administration of two medications: paclitaxel and cisplatin. Both medications are given through an intravenous infusion, which means they are delivered directly into your bloodstream through a vein.

    The dosage for cisplatin is 100 mg per square meter of body surface area. The treatment is bidirectional, meaning it is administered both intraperitoneally (directly into the abdominal cavity) and systemically (throughout the body).

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment. Any side effects or complications will be recorded and managed according to the study protocol.

    Your overall survival and disease-free survival will be evaluated at 1, 3, and 5 years after the treatment. This involves tracking the time from surgery to any recurrence of the disease or other health changes.

  6. Step 6

    Quality of life assessment

    At the end of the treatment, your quality of life will be assessed using specific questionnaires. These assessments aim to understand the impact of the treatment on your daily life and well-being.

Who can join the trial?

12 criteria

  • Women aged between 18 and 70 years.
  • Confirmed diagnosis of **FIGO stage IIIB-C/IV epithelial ovarian cancer** (a specific type of ovarian cancer).
  • Underwent **CC0 complete cytoreduction** (a surgical procedure to remove visible cancer) without digestive anastomosis (no reconnection of the digestive tract).
  • Signed the **written informed consent** to participate in the study.
  • No presence of **extraperitoneal disease** (cancer spread outside the abdominal cavity).
  • Good overall health status, with a **Karnofsky index** greater than 70 or a **Performance status** of 2 or less (measures of a patient's ability to perform daily activities).
  • Normal **liver function**, with specific blood test results within acceptable limits.
  • Normal **kidney function**, with specific blood test results within acceptable limits.
  • Healthy **bone marrow function**, with specific blood test results showing adequate levels of neutrophils, hemoglobin, and platelets.
  • No serious heart, lung, liver, kidney, or neurological diseases that would make major surgery unsafe.
  • Negative pregnancy test for women who can have children, done at the screening visit.
  • Received **neoadjuvant chemotherapy** (treatment given before the main treatment) with a total of 3 systemic cycles.

Who cannot join the trial?

3 criteria

  • Patients who do not have **ovarian cancer** cannot participate.
  • Only **female** patients are eligible for the study.
  • Patients who are part of a **vulnerable population** are not eligible. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Cisplatin is a type of chemotherapy drug used in this clinical trial. It is designed to kill cancer cells or stop them from growing and dividing. In this study, cisplatin is administered directly into the abdominal area after surgery to remove as much of the cancer as possible. This method is known as intraperitoneal chemotherapy, and it aims to target any remaining cancer cells in the abdomen more effectively.

What is already known about the treatment

Cisplatin – Cisplatin is administered as a chemotherapy drug, typically given through an intravenous (IV) infusion, and in this study, it is also applied directly into the abdominal cavity (intraperitoneal administration) during surgery. It is currently being investigated in clinical trials for its effectiveness and safety in treating advanced ovarian cancer, particularly after surgery. The main therapeutic use of cisplatin is to treat various types of cancer, including ovarian cancer, by damaging the DNA of cancer cells, which prevents them from dividing and growing. Cisplatin belongs to a class of drugs known as platinum-based antineoplastic agents, which are used to kill or stop the growth of cancer cells.

Investigated diseases

Ovarian cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often starts on the outer surface of the ovary and can spread to other parts of the pelvis and abdomen. The disease progresses through stages, beginning with localized growth in the ovaries and potentially advancing to involve nearby pelvic organs. As it progresses, it may spread to the lining of the abdomen and beyond, affecting other organs. The progression can lead to the accumulation of fluid in the abdomen, known as ascites. Symptoms may include bloating, pelvic pain, and changes in bowel habits, which often appear as the disease advances.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502691-23-00Protocol codeIMIB-BICOV-2022-01Estimated enrolment20 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

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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).