Study on Dosing Methods of Cisplatin for Women with Advanced Ovarian Cancer

4 1 1 1

What is this study about?

This clinical trial is focused on studying advanced forms of ovarian cancer, specifically FIGO stage III high-grade serous ovarian cancer, peritoneal cancer, or fallopian tube carcinoma. The treatment being investigated is a chemotherapy method called hyperthermic intraperitoneal chemotherapy (HIPEC), which involves delivering heated chemotherapy directly into the abdominal cavity. The medication used in this study is cisplatin, a common chemotherapy drug. The trial aims to compare two different ways of determining the dose of cisplatin: one based on body surface area and the other based on the concentration of the drug.

The purpose of the study is to evaluate which dosing method is more effective for patients with advanced-stage ovarian cancer. Participants will receive cisplatin through a process called intraperitoneal use, where the drug is infused directly into the abdominal area. The study will monitor the concentration of cisplatin in both tumor and normal tissues at various times during the treatment. Additionally, the study will assess the safety and potential side effects of the treatment.

Throughout the study, researchers will also track the recurrence-free survival and overall survival of participants. The trial is expected to continue until March 2025, with the goal of providing valuable insights into the most effective dosing strategy for cisplatin in treating advanced ovarian cancer. This research could potentially improve treatment outcomes for patients facing this challenging disease.

1 joining the study

Participation begins after providing a signed and written informed consent.

Eligibility is confirmed based on specific health criteria, including adequate kidney, bone marrow, and liver function, and being fit for major surgery.

2 preparation for treatment

Patients must have a confirmed diagnosis of FIGO stage III high-grade serous ovarian cancer, peritoneal cancer, or fallopian tube carcinoma.

Prior to the main treatment, patients receive at least three courses of chemotherapy with carboplatin and paclitaxel.

3 surgery and chemotherapy

Eligible patients undergo interval cytoreductive surgery, which aims to remove as much of the tumor as possible.

During surgery, patients receive cisplatin through a method called hyperthermic intraperitoneal chemotherapy (HIPEC).

Cisplatin is administered as a solution for infusion directly into the abdominal cavity.

4 monitoring and evaluation

The primary focus is on measuring the concentration of platinum (Pt) in tumor tissue at the end of a 90-minute perfusion.

Secondary evaluations include assessing toxicity, Pt concentration in normal tissue, and recurrence-free and overall survival rates.

5 follow-up

Patients are monitored for any side effects and overall health outcomes.

The study aims to compare body surface area-based dosing with concentration-based dosing of cisplatin.

Who Can Join the Study?

Must have signed and written informed consent, meaning you agree to participate after understanding the study.
Must have adequate kidney function. This means your kidneys are working well enough, with a creatinine clearance of at least 60 ml/min. This is a measure of how well your kidneys filter waste.
Must be fit for major surgery, with a WHO performance status of 0-2. This is a scale that measures your ability to perform daily activities, where 0 means fully active and 2 means you can do some activities but not work.
Must have adequate bone marrow function. This means your blood levels are healthy, with hemoglobin (a protein in red blood cells) above 5.5 mmol/L, leukocytes (white blood cells) above 3 x 10⁹/L, and platelets (cells that help with blood clotting) above 100 x 10⁹/L.
Must be able to understand the patient information provided about the study.
Must be at least 18 years old.
Must be eligible for interval cytoreductive surgery with OVHIPEC. This means you have a specific type of surgery planned after some initial treatment. The cancer must be confirmed as FIGO stage III high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.
If only a cell test (cytology) is done to confirm ovarian cancer, certain tests like immunohistochemistry should be considered, based on the pathologist’s decision.
Must have received at least 3 courses of neo-adjuvant chemotherapy with carboplatin and paclitaxel. This is treatment given before surgery to shrink the tumor.
After 2 cycles of chemotherapy, the cancer should not have progressed.
Local bowel involvement, certain abdominal wall metastases, or umbilical lesions (stage IV) are allowed if they can be surgically removed.
Must have peritoneal disease present at the start of the surgery. This means cancer is in the lining of the abdomen.
Must have been treated with optimal or complete interval cytoreductive surgery, meaning the surgery successfully removed as much cancer as possible.
Must have adequate liver function. This means your liver is working well, with ALT, AST, and bilirubin levels less than 2.5 times the normal upper limit. These are tests that measure liver health.

Who Cannot Join the Study?

Patients who do not have FIGO stage III high grade serous ovarian cancer, peritoneal cancer, or fallopian tube carcinoma. These are specific types of cancers affecting the ovaries, the lining of the abdomen, or the fallopian tubes.
Patients who are not female. This study is only for female participants.
Patients who are not within the specified age range. The study is for certain age groups, but the exact ages are not specified here.
Patients who belong to a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2022

Trial locations

Investigated drugs:

Cisplatin

Cisplatin is a chemotherapy medication used to treat various types of cancer, including ovarian cancer. In this clinical trial, cisplatin is being used as part of a treatment called hyperthermic intraperitoneal chemotherapy (HIPEC). This involves delivering heated chemotherapy directly into the abdominal cavity to target cancer cells more effectively. The trial is comparing two different methods of dosing cisplatin: one based on the patient’s body surface area (BSA) and the other based on the concentration of the drug. The goal is to determine which dosing method is more effective for treating advanced ovarian cancer.

Investigated diseases:

Ovarian cancer

High Grade Serous Ovarian Cancer – This is a type of ovarian cancer characterized by the rapid growth of abnormal cells in the ovaries. It often presents at an advanced stage, making it challenging to detect early. The cancer cells can spread to nearby tissues, including the peritoneum and fallopian tubes. As the disease progresses, it may cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The cancer is known for its aggressive nature and tendency to recur after initial treatment.

Peritoneal Cancer – This cancer occurs in the peritoneum, a thin layer of tissue lining the abdomen. It shares similarities with ovarian cancer, particularly in its symptoms and progression. The disease often spreads within the abdominal cavity, leading to symptoms like abdominal pain, swelling, and digestive issues. Peritoneal cancer is typically diagnosed at an advanced stage due to its subtle early symptoms. As it advances, it can affect the function of abdominal organs and cause fluid buildup in the abdomen.

Fallopian Tube Carcinoma – This rare cancer originates in the fallopian tubes, which connect the ovaries to the uterus. It is often detected at a later stage due to non-specific symptoms such as pelvic pain and abnormal vaginal bleeding. The cancer can spread to nearby organs and tissues, including the ovaries and peritoneum. As it progresses, it may cause symptoms similar to those of ovarian cancer, such as abdominal discomfort and bloating. The disease is often associated with genetic factors and may be linked to hereditary cancer syndromes.

Trial ID:

2024-514711-99-00

NCT ID:

NCT05406674

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Dosing Methods of Cisplatin for Women with Advanced Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?