Active not recruitingNAINTERVENTIONAL

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

This study, called TRUST, is for women with advanced ovarian cancer. It wants to find out if there's a better time to have surgery alongside chemotherapy. One group of patients will have surgery first, followed by chemotherapy. Another group will have some chemotherapy first, then surgery, and then more chemotherapy. Researchers will compare these two approaches to see if one leads to better overall outcomes, like how long people live after treatment. The study aims to improve care for women with this type of cancer.

At a glance

Status

Active not recruiting

Phase

Sponsor

AGO Study Group

Enrolment target

797

Start

01 Jul 2016

Estimated completion

01 Dec 2025

Ovarian Cancer

What is this study about?

This study is particularly for women who have advanced ovarian cancer. When ovarian cancer is advanced, it means it has spread beyond the ovaries. The main goal of this research is to figure out the best timing for surgery in relation to chemotherapy. Cancer treatment often involves a combination of different methods, and for ovarian cancer, surgery to remove as much of the tumour as possible, along with chemotherapy (powerful medicines that kill cancer cells), are key.

The study is split into two main groups. In one group, patients will have surgery first to remove as much of the cancer as possible. This is then followed by a course of chemotherapy. In the other group, patients will start with a few cycles of chemotherapy first, before having surgery to remove the cancer. After surgery, they will then continue with more chemotherapy. Researchers believe that the timing of surgery might make a difference, and they want to see if one of these approaches leads to a better chance of survival or other benefits for patients.

All patients in the study will receive standard treatments that aim to remove as much cancer as possible during surgery, following guidelines. This includes removing the womb, ovaries, fallopian tubes, and often other affected parts like sections of the bowel or other organs. The chemotherapy used will also be standard, well-known treatments for ovarian cancer. The study is carefully designed to compare these two timing strategies to find the most effective way to help women with advanced ovarian cancer.

Key takeaways

This study compares two ways of timing surgery and chemotherapy for advanced ovarian cancer.
It aims to find the best treatment sequence for patients.
All treatments given are standard for advanced ovarian cancer.
You'll receive close monitoring and care throughout the study.
Your participation helps improve ovarian cancer treatment for everyone.

Who may be eligible?

This study is looking for women aged 18 or older who have been recently diagnosed with advanced epithelial ovarian cancer (stages IIIB-IV). Your doctor must believe that surgery can remove all or most of the cancer. You'll also need to be in generally good health, meaning you can carry out daily activities without too much difficulty.

There are some specific health requirements, for example, your blood, kidney, and liver test results need to be within certain ranges. Also, any nerve damage (neuropathy) you might have should be mild. You will also need to provide your written consent to join the study.

You won't be able to join if you have other types of ovarian cancer, if your cancer has come back, or if you've already had chemotherapy or radiation for ovarian cancer. Other reasons for not being able to join include having certain other cancers in the last five years, severe blood clotting problems, significant lung or liver spread that can't be operated on, or if you are pregnant.

Quick self-check

Are you a woman aged 18 or over?
Have you recently been diagnosed with advanced epithelial ovarian cancer?
Do you feel generally well enough to go through major surgery and chemotherapy?
Do you have good kidney, liver, and blood test results?
Have you NOT had chemotherapy or radiation for ovarian cancer before?
Are you NOT pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll first go through a screening process where doctors confirm you meet all the requirements. Once you're enrolled, you'll be randomly assigned to one of two groups: either surgery first, followed by chemotherapy, or chemotherapy first, then surgery, then more chemotherapy. This is decided by chance, like flipping a coin, so it's fair.

Both groups will have major surgery to remove the cancer. This surgery typically involves an incision in your tummy an may include removing your womb, ovaries, fallopian tubes, and any other parts of organs where cancer has spread. After surgery, or between chemotherapy cycles, you'll receive a standard course of chemotherapy, usually platinum and taxane-based drugs, given over 6 cycles.

Throughout the study, you'll have regular hospital visits for blood tests, physical exams, and scans (like CT scans) to monitor your health and how the treatment is working. The exact number of visits and their timing will depend on which group you're in and your treatment schedule. You'll continue to be followed by the study team after your main treatment is complete, to track your long-term health and any effects of the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would receive closely monitored, guideline-recommended treatment for your advanced ovarian cancer. You would also contribute to medical knowledge that could help future patients. However, you might experience side effects from the surgery and chemotherapy, which can include things like tiredness, sickness, hair loss, and an increased risk of infection. As with all major surgeries, there are risks associated with the procedure itself, such as bleeding or infection. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Memorial Sloan Kettering Cancer Center
New York, United States
Medical University of Vienna
Vienna, Austria
University Hospital, Rigshospitalet
Copenhagen, Denmark
Institut Bergonié
Bordeaux, France
Hôpital Européen Georges Pompidou (HEGP)
Paris, France
Institute Gustave Roussy
Villejuif, France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie
Berlin, Germany
Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe
Dresden, Germany
Kaiserswerther Diakonie; Florence-Nightingale-Hospital
Düsseldorf, Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, Germany
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München
München, Germany

+8 more sites — see the official record for the full list.

Common questions

What is 'advanced' ovarian cancer?

Advanced ovarian cancer means the cancer has spread beyond the ovaries to other parts of your body, but doctors believe it can still be treated effectively.

What is 'chemotherapy'?

Chemotherapy is a type of medicine that uses strong chemicals to kill fast-growing cancer cells in your body.

Why compare timing of surgery?

Doctors want to find out if it's better to have surgery first, or a few cycles of chemotherapy first, in order to get the best results for patients with advanced ovarian cancer.

Will I get good treatment if I join this study?

Yes, all patients in this study will receive standard, guideline-recommended treatments for advanced ovarian cancer, regardless of which group they are in.

Can I leave the study if I change my mind?

Absolutely, you can decide to leave the study at any point, and it won't affect the care you receive for your cancer.