Study on the Effectiveness and Safety of Cisplatin and Paclitaxel in Advanced Ovarian Cancer Patients After Surgery

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.12.2022

Trial locations

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.

Investigated diseases:

Ovarian cancer

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 ID:

2022-502691-23-00

Protocol code:

IMIB-BICOV-2022-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Cisplatin and Paclitaxel in Advanced Ovarian Cancer Patients After Surgery

What is this study about?

Who Can Join the Study?

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