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Study on Hyperthermic Intraperitoneal Chemotherapy with Cisplatin for Patients with Recurrent Ovarian Cancer

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 treatment of ovarian cancer that has returned after initial treatment. The treatment being tested is called Hyperthermic Intraperitoneal Chemotherapy (HIPEC), which involves delivering heated chemotherapy directly into the abdominal area. The specific medication used in this treatment is cisplatin, which is administered as a solution for injection. The purpose of the study is to see if this approach can improve the survival of patients with ovarian cancer relapse compared to those who do not receive HIPEC.

Participants in the study will be randomly assigned to one of two groups. One group will receive the HIPEC treatment with cisplatin, while the other group will not receive HIPEC. The study will monitor the participants over a period to assess their overall survival and any side effects they may experience. The study will also look at other factors such as the time until the cancer returns, the quality of life of the participants, and any pain they may experience.

Throughout the study, various assessments will be conducted to gather information on the effectiveness and safety of the treatment. This includes monitoring for any complications or side effects, particularly focusing on kidney health, as well as evaluating the participants' quality of life and pain levels. The study aims to provide valuable insights into whether HIPEC with cisplatin can be a beneficial treatment option for patients with recurrent ovarian cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must meet specific criteria, including being at least 18 years old, having certain blood cell counts, and no contraindications to anesthesia.
The patient must have a history of ovarian cancer with a resectable relapse and must have completed previous treatments.
The patient must sign an informed consent form before any study-specific procedures begin.
Step 2
Pre-operative chemotherapy
The patient will receive second-line platinum-based chemotherapy, which may include combinations such as carboplatin-paclitaxel or carboplatin-caelix.
This treatment is administered before surgery and must be completed 5 to 12 weeks prior to the surgical procedure.
Step 3
Surgery
The patient will undergo complete cytoreductive surgery to remove any visible cancerous tissue.
This step is crucial for patients with intraperitoneal relapse, ensuring that the cancer is resectable without distant metastasis.
Step 4
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Following surgery, the patient may receive cisplatin through hyperthermic intraperitoneal chemotherapy (HIPEC), which involves administering heated chemotherapy directly into the abdominal cavity.
This treatment aims to improve overall survival by targeting any remaining cancer cells.
Step 5
Post-treatment monitoring
The patient's overall survival and relapse-free survival will be monitored, with evaluations including clinical evidence, biological markers, and medical imaging.
Quality of life and pain levels will be assessed using specific questionnaires and scales.
Treatment toxicity, particularly renal toxicity, will be evaluated, and any morbidity will be monitored until the 60th day after surgery.
Step 6
Study completion
The study is estimated to conclude by April 26, 2025, with ongoing assessments of the patient's health and treatment outcomes.

Who can join the trial?

14 criteria

Patient must be **18 years or older**.
Blood health must be good, with **certain levels of white blood cells** and **platelets**.
No issues that prevent the use of **general anesthesia** for major surgery.
Patient must be informed about the study and sign a **consent form** before any study procedures begin.
Must have **medical or public health insurance** coverage.
Women who can have children must use **effective birth control** during treatment and for 6 months after treatment ends.
Must have a **Performance Status** of less than 2, which means the patient can carry out daily activities with little or no help.
Must have had previous treatment for **epithelial ovarian cancer**.
Patient must have a **relapse** of cancer in the abdomen that can be surgically removed, with no spread to distant parts of the body, except for certain conditions that can be treated.
Must have received **second-line chemotherapy** with specific drugs before surgery.
Must have had **complete surgery** to remove cancer.
The time between the last chemotherapy session and surgery must be **between 5 and 12 weeks**.
No **liver problems**, with certain levels of liver enzymes and bilirubin.
No **kidney problems**, with certain levels of creatinine and kidney function.

Who cannot join the trial?

5 criteria

Patients who have a type of cancer other than ovarian epithelial cancer with a resectable relapse in the abdominal area.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not female or male, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Grenoble Alpes
Verified
La Tronche, France
Centre Francois Baclesse
Verified
Caen, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a treatment method used in this clinical trial. It involves delivering heated chemotherapy directly into the abdominal cavity during surgery. The heat is believed to enhance the effectiveness of the chemotherapy, helping to kill more cancer cells. This approach is being tested to see if it can improve survival rates for patients with ovarian cancer relapse.

Cisplatin

What is already known about the treatment

HIPEC (Hyperthermic Intraperitoneal Chemotherapy) – This treatment involves administering heated chemotherapy directly into the abdominal cavity, typically during surgery. It is currently being studied in clinical trials for its effectiveness in treating ovarian epithelial cancer, particularly in cases of resectable relapse. The main therapeutic indication is to improve overall survival rates in patients with ovarian cancer relapse. The mechanism of action involves the direct application of heated chemotherapy, which enhances the drug's effectiveness by increasing its penetration into cancerous tissues and improving its cytotoxic effects. HIPEC is classified under localized chemotherapy treatments.

Investigated diseases

Ovarian epithelial cancer – This is a type of cancer that begins in the layer of cells covering the ovary. It is the most common form of ovarian cancer and often goes undetected until it has spread within the pelvis and abdomen. The disease progresses as cancer cells grow and multiply, potentially spreading to other parts of the body. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. As the cancer advances, it can lead to the formation of tumors and fluid accumulation in the abdomen. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.