RecruitingPhase II/IIIInterventional

A trial assessing preoperative chemotherapy in patients with locally advanced but operable colon cancer

Bowel cancer is usually treated with surgery first, followed by chemotherapy to kill off any remaining cancer cells. The FOxTROT research study aims to find out if giving treatment before surgery works better. An earlier study showed that having chemotherapy first was safe and reduced the chance of cancer returning in younger, fitter patients. This new set of trials tests whether this approach also helps older people, people with other medical conditions, and those with specific genetic changes in their tumour. Participants either receive treatment before their operation or have standard care with surgery first. By testing gentler therapies and targeted drugs, the research aims to find safer, more effective care plans tailored to each individual patient.

At a glance

Status

Recruiting

Phase

Phase II/III

Sponsor

University of Leeds

Enrolment target

1,703

Start

07 Feb 2022

Estimated completion

01 Apr 2027

Locally advanced but operable colon cancer

What is this study about?

Bowel cancer is one of the most common cancers in the UK. The standard approach for cancer in the colon has long been an operation to remove the tumour, followed by a course of chemotherapy to stop it coming back. While this helps many people, doctors want to find treatments that make surgery safer and lower the risk of cancer returning even further.

The FOxTROT research team previously ran a trial showing that giving chemotherapy before surgery helped shrink tumours and lowered the chance of cancer returning in younger, fitter patients. Now, researchers want to see if this approach can be safely offered to a wider range of people, including older patients and those with other health conditions.

The study is split into smaller trials depending on your health and tumour type. For example, FOxTROT 2 tests a gentler chemotherapy plan for older or less fit patients, while FOxTROT 3 is for younger and fitter patients. Other branches, FOxTROT 4 and 5, test targeted treatments and immunotherapy for tumours with specific genetic changes (such as BRAF or dMMR).

This research matters because it could lead to more personalised treatment across the NHS. By giving cancer therapies before surgery, doctors hope to make operations easier, reduce surgical complications, and give patients the best chance of living cancer-free.

Key takeaways

The FOxTROT trial tests whether cancer therapy works better before surgery rather than after.
It includes older adults, less fit patients, and people with specific tumour genes.
Earlier results showed treatment before surgery is safe and can lower the risk of cancer returning.
You will receive close monitoring from your specialist cancer team throughout.
Participation is voluntary, and you can withdraw at any point without losing standard NHS care.

Who may be eligible?

You may be able to join this trial if you are 18 or older and have been diagnosed with colon cancer that has grown locally but can still be safely removed with surgery. Your treatment must be aimed at curing the cancer completely.

Because this study includes several groups, your cancer specialist (oncologist) will check your age, overall fitness, blood tests, and tumour genetics to see which branch is right for you. Older patients or those with existing health problems will be considered for gentler options, while younger and fitter patients may receive standard strength treatments.

You cannot take part if your cancer has spread widely to distant parts of the body (advanced metastatic cancer) or if your liver, kidneys, or blood counts are not working well enough to cope with the medication. If you or your partner could become pregnant, you must agree to use reliable contraception during and shortly after the study.

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.

I am aged 18 or over.
I have been diagnosed with colon cancer that can be removed with surgery.
My cancer has not spread to distant parts of my body.
A sample from my tumour is available for genetic testing.
I am able to attend regular hospital visits for treatment and monitoring.

Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into a treatment group chosen by your cancer team based on your tumour type and fitness. Depending on the group, you may receive cancer treatment (such as chemotherapy drips, tablets, or immunotherapy) before your operation, or you may receive standard care with surgery first. Pre-surgery treatment usually lasts several weeks, followed by a 3 to 4 week rest to let your body recover before your operation. After surgery, there is a 4 to 8 week rest period before your team decides if you need any further treatment. Throughout the trial, you will attend regular hospital appointments for check-ups, blood tests, and scans to monitor your health. The trial aims to follow patients for several years to see how well the treatment worked long term.

Potential risks and benefits

Potential benefits include having your tumour shrunk before surgery, which may make the operation simpler and lower the risk of post-surgery complications. It may also lower the chance of the cancer coming back. However, there is no guarantee of direct benefit. Potential risks include common chemotherapy side effects, such as sickness, tiredness, nerve tingling, and a higher risk of infection. There is also a small risk that the tumour could grow during treatment, which might require an earlier operation. Your medical team will monitor you very closely throughout the trial. Taking part is entirely voluntary, and you can withdraw at any time without your regular NHS care being affected.

Locations (77)

Airedale General Hospital
Approximate
Keighley, England
St Bartholomew's Hospital
Approximate
London, England
Ysbyty Gwynedd
Approximate
Bangor, Wales
Bradford Royal Infirmary
Approximate
Bradford, England
Calderdale Rotal Hospital and Huddersfield Royal Infirmary
City only
Huddersfield, England
Addenbrooke's Hospital
Unverified
Cambridge, England
West Middlesex University Hospital
Unverified
Isleworth, England
Chesterfield Royal Hospital
Unverified
Chesterfield, England
Countess of Chester Hospital
Unverified
Chester, England
Darlington Memorial Hospital
Unverified
Darlington, England
Macclesfield District General Hospital
Unverified
Macclesfield, England
Ipswich Hospital
Unverified
Ipswich, England

Common questions

Can I choose which treatment group I join?

No. Your doctor will test your tumour and assess your health to see which trial branch suits you. Within that branch, a computer system usually decides by chance whether you get treatment before surgery or standard surgery first.

Will having chemotherapy first delay my surgery dangerously?

Your team keeps a close eye on you. The planned delay is short and carefully timed. If your tumour causes urgent symptoms, doctors will stop the trial drug and carry out your operation straight away.

What happens if the side effects are too strong?

Tell your care team immediately. They can lower your dose, give you medications to ease the side effects, or pause the treatment if needed to keep you safe.

Will taking part cost me anything?

No. The study medications and extra trial tests are provided free of charge through the NHS and trial funders. You may be able to claim back travel expenses depending on your local hospital.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason. Your doctors will continue to give you the standard NHS care best suited to your condition.

How to find out more

Claire Dimbleby

FOxTROT@leeds.ac.uk - Official trial record

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