Not yet recruitingPHASE3INTERVENTIONAL

ICRA Randomised Controlled Trial

This important study, called ICRA, is looking into the best timing for surgery for women with advanced ovarian cancer. Currently, some women have surgery after a few cycles of chemotherapy (known as interval surgery), while others might have more chemotherapy before surgery (delayed surgery). Doctors want to find out if one of these timings leads to a better chance of survival for patients. Previous research has given mixed results, partly because studies weren't always big enough or designed in the same way. The ICRA trial aims to provide clear answers by comparing these two approaches in a large, well-designed study. Your participation could help improve care for women with ovarian cancer in the future.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

NHS Grampian

Enrolment target

682

Start

31 Jan 2026

Estimated completion

31 Jan 2034

Ovary Cancer

What is this study about?

This study, called ICRA, is looking at the best way to treat advanced ovarian cancer. When ovarian cancer has spread, the usual treatment involves surgery to remove as much of the cancer as possible, followed by chemotherapy. Sometimes, doctors give chemotherapy first to shrink the cancer before surgery. This is called 'neoadjuvant chemotherapy'.

There are two main approaches after this initial chemotherapy. One is called 'interval cytoreduction surgery', where surgery happens after about three or four cycles of chemotherapy. The other is 'delayed cytoreduction surgery', where surgery might happen after more than four cycles of chemotherapy. Doctors have noticed that in real life, the number of chemotherapy cycles before surgery can vary a lot, sometimes due to how complex the surgery might be, or even waiting list times.

This trial is really important because we don't have enough clear information about whether waiting longer for surgery (after more chemotherapy) is as good as having surgery sooner (after fewer chemotherapy cycles). Some earlier studies suggested that having surgery sooner might lead to better survival, but these studies weren't always perfectly designed. The ICRA trial aims to properly compare these two timings to see which one gives women with advanced ovarian cancer a better chance of long-term survival. The goal is to figure out the best treatment plan for these patients.

Key takeaways

This study compares two timings for surgery in advanced ovarian cancer.
It aims to find out which surgical timing, after chemotherapy, gives better survival.
You would receive either earlier surgery (interval) or slightly later surgery (delayed) after chemotherapy.
Participation involves your usual cancer treatment, with close monitoring.
The findings could help improve future treatments for women with ovarian cancer.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a woman aged 18 or over. You must have been diagnosed with advanced ovarian cancer, or cancer of the fallopian tube or the thin lining of your abdomen (peritoneum). Specifically, the cancer needs to be a certain type (high-grade serous or endometrioid) and at an advanced stage (Stage IIIA to IVB).

Doctors would have decided that your cancer couldn't be completely removed by surgery right away, so you would have already started chemotherapy. After about three cycles of chemotherapy, doctors need to believe that surgery to remove the cancer would now be possible. Importantly, you also need to be well enough to have both surgery and chemotherapy.

There are some reasons why you wouldn't be able to join. For example, if you're having initial surgery right away (without chemotherapy first) or if your cancer has come back. Certain rare types of ovarian cancer are also excluded, as are other cancers happening at the same time. If you're pregnant or breastfeeding, or if doctors think you're not well enough for surgery or chemotherapy, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have advanced ovarian cancer (or fallopian tube/peritoneal cancer)?
Has your cancer type been identified as high-grade serous or endometrioid?
Have you started chemotherapy because your cancer couldn't be removed with initial surgery?
Do your doctors think surgery would now be possible after initial chemotherapy?
Are you generally well enough for both surgery and chemotherapy?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would first receive a few cycles of chemotherapy. After this, you would be randomly assigned to one of two groups. One group would have surgery relatively soon after these initial cycles (interval surgery). The other group would have more chemotherapy cycles before their surgery (delayed surgery). You would then continue to receive further chemotherapy after your surgery, just as you would under standard care.

The study involves regular check-ups, scans, and blood tests to monitor your health and how well the treatment is working. The total duration of your participation would depend on your specific treatment plan and follow-up schedule, but it typically involves monitoring for several years to track your long-term health and survival. All visits and assessments would be part of your normal cancer treatment, with some additional data collection for the study.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that it might help identify the best treatment timing for advanced ovarian cancer, which could directly improve your chances of survival. You would receive close monitoring and care throughout the study. However, there's always a risk that the treatment timing you receive might not be the most effective for you personally, or that you might experience side effects from the chemotherapy or surgery, as with any cancer treatment. You are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to find out if having surgery for advanced ovarian cancer after fewer chemotherapy cycles leads to better survival compared to having surgery after more chemotherapy cycles.

What does 'randomised controlled trial' mean?

It means you'd be put into one of the treatment groups by chance, like flipping a coin. This helps make sure the results are fair and not biased.

Will I know which treatment group I'm in?

Yes, you and your doctors will know which treatment plan (interval surgery or delayed surgery) you are assigned to.

How long will I be involved in the study?

Your involvement typically lasts several years, covering your treatment period and long-term follow-up to track your health outcomes.

What kind of ovarian cancer is this study for?

This study is for common types of advanced ovarian cancer, specifically high-grade serous or endometrioid types, or similar cancers of the fallopian tube or peritoneum.

How to find out more

Faiza Gaba

faiza.gaba1@abdn.ac.uk +442034567890 Official trial record

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