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 study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Cjtysizwt Uaacqtlqyudxci Setpcxsco	Woluwe-Saint-Lambert	Belgium
Ibzhsesp Rnhqmteb Du Callqe Do Mpkibpvffsx	Montpellier	France
Crjjnuyk Mnzzoytc	Rouen	France
Isfqefop Phfvnbmexdqeypp Ccimpq Cjgaui	Marseille	France
Cstivk Ontaz Lmdoqgg	Lille	France
Hwvgegcw Uarmdznqiamayn Sxzwjxnjsr &pauyrx Hfabglk dw Hcmsrmtjmpv	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2019
France	Not recruiting	01.04.2019

Trial locations

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.

Investigated diseases:

Fallopian tube cancer

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 ID:

2024-514706-31-01

NCT ID:

NCT03842982

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?