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A Study of Carboplatin Given Directly into the Abdomen After Surgery in Elderly and Frail Patients with Ovarian Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves women with ovarian cancer, which is a disease that affects the ovaries, the female organs that produce eggs. The study also includes women with cancer of the fallopian tubes, which are the tubes connecting the ovaries to the womb, and cancer of the peritoneum, which is the lining of the abdominal cavity. These cancers are often treated with surgery to remove as much of the cancer as possible, followed by chemotherapy, which is medication that kills cancer cells. The treatment being tested in this study uses carboplatin, a chemotherapy drug that is delivered directly into the abdominal cavity during surgery at normal body temperature. This method is called Normothermic Intraperitoneal Chemotherapy. The drug is given through a route called intraperitoneal use, which means it is placed inside the abdominal cavity rather than given through a vein.

The purpose of this study is to check whether this treatment method is safe and practical for older and more fragile women with advanced ovarian cancer who may not be suitable for a similar treatment that uses heat. The study will look at how the treatment affects the body, including any side effects or complications that may occur during or after surgery. It will also measure how the drug moves through the body and how it affects both healthy tissue and cancer tissue in the abdominal area. Additionally, the study will examine how this treatment affects inflammation and blood flow in the tissues.

Women participating in this study will first receive chemotherapy before surgery to shrink the cancer. Then, during surgery to remove the cancer, they will receive carboplatin directly into the abdominal cavity. After surgery, they will be monitored for any complications and side effects. The study will track how long patients stay in the hospital, whether they need additional surgeries, and how soon they can start additional chemotherapy after surgery. The study will also look at quality of life through questionnaires and will measure various biological markers in both tissue samples and blood to understand how the treatment works. The entire study is expected to continue until 2027.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Surgery and treatment administration
Your surgeon will perform cytoreductive surgery, which is an operation to remove as much of the cancer tissue as possible from your abdomen. The goal is to leave any remaining cancer deposits smaller than 2.5 millimeters.
During the same operation, after the cancer tissue has been removed, you will receive carboplatin directly into your abdominal cavity. This is called intraperitoneal chemotherapy, which means the medication is placed inside your abdomen rather than given through a vein.
The carboplatin will be administered at normal body temperature. This approach is called Normothermic Intraperitoneal Chemotherapy or NIPEC.
The specific dosage and duration of the carboplatin administration during surgery will be determined by your medical team based on the treatment protocol.
Step 2
Hospital recovery period
After your surgery, you will remain in the hospital for recovery. The length of your hospital stay will depend on how your body responds to the surgery and treatment.
Your medical team will monitor you for any complications or side effects related to both the surgery and the carboplatin treatment.
If any complications occur that require additional surgery, this will be addressed during your hospital stay or recovery period.
Step 3
Follow-up chemotherapy
After you have sufficiently recovered from surgery, you will begin adjuvant chemotherapy. This is additional chemotherapy treatment given after surgery to help prevent the cancer from returning.
The timing of when this chemotherapy starts will depend on your recovery from the surgery.
You will receive a total of three cycles of adjuvant chemotherapy.
The specific medications, dosages, and schedule for this chemotherapy will be determined by your oncology team.
Step 4
Monitoring and assessments
Throughout your participation in the trial, your medical team will monitor you for any side effects or complications.
You will be asked to complete questionnaires about your quality of life at various points during your treatment.
If you need to be readmitted to the hospital after your initial discharge, or if you require additional surgery, this will be documented and managed by your medical team.
Your medical team will collect information about how the carboplatin is processed by your body, including measurements from your abdominal tissue and blood samples.
Tissue samples may be collected to assess how your body responds to the treatment at a cellular level.

Who can join the trial?

9 criteria

You must sign a document showing that you agree to take part in the study after receiving information about it, which is called informed consent.
You must be able to understand the study information and make your own decision about joining.
You must be 70 years old or older.
You must be a woman with a specific type of ovarian cancer, which is a cancer that affects the ovaries, or fallopian tube cancer, which affects the tubes connecting the ovaries to the womb, or peritoneal cancer, which affects the lining of the belly area. The cancer must be at an advanced stage called FIGO stage III-IV, which means the cancer has spread beyond the ovaries. You must be planning to have surgery to remove as much of the cancer as possible, which is called cytoreductive surgery, after receiving some chemotherapy treatment first. If you have stage IV cancer, you can only join if the cancer that has spread can be removed by surgery within the belly area, or if cancer that spread outside the belly has completely gone away after three rounds of chemotherapy treatment given before surgery.
Your general health and ability to carry out daily activities must be at a certain level, measured by something called performance status 1-3, which means you may have some limitations but can still care for yourself to some degree.
Your overall health condition must be suitable for surgery and anesthesia, rated as ASA scores I-III. This is a scoring system used by doctors who give anesthesia to assess how healthy you are before surgery.
Your kidneys, which filter waste from your blood, your liver, which processes substances in your body, and your bone marrow, which makes blood cells, must all be working normally before surgery.
During surgery, the doctors must be able to remove the cancer so that any remaining pieces are less than 2.5 millimeters in size, which is very small.
You must live in a specific geographic area in Denmark called the Region of Southern Denmark.

Who cannot join the trial?

4 criteria

You cannot participate if you are male, as this study only includes female patients
You cannot participate if you are under 18 years old, as this study is only for adult patients
You cannot participate if you do not have ovarian cancer, which is a type of cancer that starts in the ovaries, the organs in women that produce eggs
You cannot participate if you are healthy and do not have the medical condition being studied

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

Carboplatin is a chemotherapy medication used to treat various types of cancer, including ovarian cancer. In this study, carboplatin will be delivered directly into the abdominal cavity at normal body temperature during surgery to help destroy any remaining cancer cells after the main tumor has been removed.

Carboplatin

What is already known about the treatment

Carboplatin – Carboplatin is a chemotherapy medication given through injection into a vein or directly into the abdominal cavity (intraperitoneal administration) that is widely used to treat various types of cancer, particularly ovarian cancer. It works by damaging the DNA inside cancer cells, which prevents them from dividing and growing, ultimately leading to their death. This drug belongs to a class of medications called platinum-based chemotherapy agents and is considered a standard treatment option in cancer care. In this clinical trial, carboplatin is being tested using a normothermic (normal body temperature) intraperitoneal method to determine if it is safe and effective for elderly or fragile ovarian cancer patients who may not tolerate more intensive treatments.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a disease that develops in the ovaries, which are the female reproductive organs that produce eggs. The cancer begins when cells in the ovaries start to grow abnormally and out of control. As the disease progresses, cancer cells can form tumors and may spread to the peritoneum, which is the lining of the abdominal cavity. The cancer can also spread to other organs in the abdomen and pelvis. In advanced stages, the disease may involve multiple areas within the abdominal cavity, including the surface of the bowel and other abdominal organs. The progression of ovarian cancer often occurs silently, with the disease advancing before symptoms become noticeable.