RecruitingPHASE2INTERVENTIONAL

Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer

This study, called ACTOv, is for women who have high-grade serous or endometrioid ovarian cancer that has returned after previous treatment and responded well to platinum-based chemotherapy before. It aims to find out if giving a chemotherapy drug called carboplatin in a more personalised way can be more effective and cause fewer side effects. Instead of a fixed dose every three weeks, the new approach, called "adaptive therapy," adjusts the dose based on changes in a blood test called CA125, which can show how much cancer is present, and how well you responded to previous treatments. Researchers hope this adaptive method could make the carboplatin work for longer, keep the cancer under control for longer, and reduce the overall amount of chemotherapy needed, leading to fewer side effects. Carboplatin is a well-established and generally well-tolerated chemotherapy drug for ovarian cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

24 May 2023

Estimated completion

01 Nov 2027

Ovarian Cancer Relapsed Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Endometrioid Carcinoma High Grade Serous Carcinoma Ovary Cancer

What is this study about?

When ovarian cancer comes back after initial treatment, doctors often use chemotherapy again. One of the main drugs for this is called carboplatin. This study, called ACTOv, is looking at a new, more tailored way to give carboplatin to women whose high-grade serous or endometrioid ovarian cancer has returned.

Currently, carboplatin is usually given at a set dose every three weeks. However, this study wants to try an "adaptive" approach. This means the dose of carboplatin might change over time based on specific information from your body. Doctors will look at your CA125 blood test results (a marker often used to monitor ovarian cancer) and how your body has reacted to past chemotherapy. The idea is that by adjusting the dose, the treatment might be more effective for longer and potentially cause fewer side effects.

The main goal is to see if this adaptive way of giving carboplatin can keep the cancer under control for a longer period and be easier to tolerate than the standard approach. Carboplatin is already a key drug in treating ovarian cancer, known for being relatively affordable and having manageable side effects. This study hopes to make it even better for patients.

Key takeaways

This study is testing a new way to give carboplatin chemotherapy for relapsed ovarian cancer.
It focuses on specific types of ovarian cancer (high-grade serous or endometrioid) that have responded to platinum-based chemotherapy before.
The new method, 'adaptive therapy,' aims to adjust chemotherapy doses based on blood tests (CA125) to improve results and reduce side effects.
Participation involves regular hospital visits, blood tests, and scans.
You can stop participating in the study at any time.
The study hopes to make existing treatments even better for patients.

Who may be eligible?

This study is for women who are at least 18 years old and have been diagnosed with a specific type of ovarian cancer that has come back. This includes high-grade serous or high-grade endometrioid cancer of the ovary, fallopian tube, or peritoneum. You would need to have shown a good response to your most recent chemotherapy treatment, which must have included a platinum drug like carboplatin. You also must have previously received a type of drug called a PARP inhibitor.

Your cancer relapse needs to have been confirmed by a scan at least six months after your last platinum-based chemotherapy. You'll also need to have good general health, including healthy blood, liver, and kidney function. If you could become pregnant, you would need to use effective contraception during the study.

However, you wouldn't be able to join if you have certain other types of ovarian cancer, if you need combination chemotherapy (this study uses carboplatin only), or if you are allergic to carboplatin. You also can't have serious side effects still lingering from previous treatments, except for hair loss or nerve problems.

Quick self-check

Are you a woman aged 18 or older?
Do you have high-grade serous or high-grade endometrioid ovarian, fallopian tube, or peritoneal cancer that has returned?
Did your most recent chemotherapy treatment (which included a platinum drug) help to control your cancer?
Have you previously received a PARP inhibitor drug?
Is your general health good enough for new treatment (good blood, liver, and kidney function)?
Are you willing and able to attend regular appointments and tests?

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

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the standard carboplatin treatment or the new adaptive carboplatin treatment. Both treatments involve receiving carboplatin every three weeks. For the adaptive treatment, your dose might change based on blood test results (CA125) and how you've responded to chemotherapy.

Before starting, you'll have various tests, including scans (CT or MRI) and blood tests, to confirm you meet the study requirements. During the study, you'll have regular blood tests, including CA125, before each carboplatin treatment. Your health will be closely monitored, and you'll have follow-up visits after your treatment finishes, initially every 6 weeks, then every 12 weeks. The total length of your participation would depend on how your treatment progresses and the follow-up schedule.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a personalised chemotherapy approach that aims to be more effective and lessen side effects. However, there's no guarantee of direct benefit for you. As with any medical treatment, there are potential risks and side effects associated with carboplatin, which your study team will discuss with you in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

University College London Hospitals
London, United Kingdom· Recruiting

Common questions

What is carboplatin?

Carboplatin is a common chemotherapy drug used to treat various cancers, including ovarian cancer. It works by slowing down or stopping the growth of cancer cells.

What's the difference between standard and adaptive therapy?

Standard therapy gives a fixed dose of chemotherapy at regular intervals. Adaptive therapy adjusts the dose based on how your body is responding, using markers like the CA125 blood test.

What is CA125?

CA125 is a protein found in the blood. For some women with ovarian cancer, levels of CA125 can be used as a marker to help doctors monitor the disease or how well treatment is working.

Will I know which treatment group I'm in?

This study uses random assignment, meaning you will be put into one of the treatment groups by chance, like flipping a coin. You might not know which group you are in, but the study team will have this information.

What if my cancer is not high-grade serous or endometrioid?

This study is specifically for high-grade serous or high-grade endometrioid ovarian cancer that has returned. Other types of ovarian cancer are not included in this study.

How to find out more

ACTOv Trial Coordinator

ctc.actov@ucl.ac.uk 02076794466 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.