A trial looking at chemotherapy before surgery for bowel cancer (FOxTROT)

Cancer type:

Bowel (colorectal) cancer
Colon cancer

Status:

Results

Phase:

Phase 3

This trial looked at whether treatment before as well as after surgery can help stop bowel cancer coming back.

The trial was supported by Cancer Research UK. It was open for people to join between 2008 and 2016. The research team presented some results at a conference in 2019, and published more results in 2023.

More about this trial

Doctors usually treat bowel (colon) cancer with surgery. When this trial was done, people often had chemotherapy after their operation. This is to help stop the cancer coming back.
 
In this trial, the researchers looked at giving some chemotherapy before surgery, and the rest after surgery. They hoped it would help:

  • make the cancer smaller and easier to remove
  • stop the cancer coming back

The main part of the trial looked at the chemotherapy drugs oxaliplatin with either 5FU or capecitabine. This is standard treatment Open a glossary item.

A smaller part of the trial looked a targeted cancer treatment called panitumumab (Vectibix) as well as chemotherapy. This part was just for people who didn’t have a change in a gene Open a glossary item called RAS. They had a normal RAS gene. 
 
The main aim of the trial was to find out if having some chemotherapy before surgery helps stop bowel cancer coming back.

Summary of results

The results showed that it is useful to have some chemotherapy before surgery for bowel cancer. It didn’t cause any more side effects or issues after surgery.

Trial design
This trial was for people who were due to have surgery and chemotherapy for bowel cancer that had not spread.

They were put into a treatment group at random. One group had chemotherapy before and after surgery. The other had chemotherapy after surgery, but not before. People in both groups had the same amount of chemotherapy in total.

Results
A total of 1,053 people joined this trial:

  • 699 people had some chemotherapy before and some after surgery
  • 354 people had surgery and then chemotherapy

Some people who had chemotherapy before their operation also had panitumumab.

Most people taking part had surgery as planned. The trial team looked at whether they could remove all of the cancer and a small area around it (the margin). They call this a complete resection. 

They found they could remove it all in:

  • 648 out of 686 people (94%) who had treatment before surgery
  • 311 out of 351 people (89%) who didn’t have treatment before surgery
     

They also looked at how many people had signs of bowel cancer, 2 years after they joined the trial. They found it was:

  • 117 out of 699 people (17%) in the group having treatment before surgery
  • 75 out of 354 (21%) in the group not having treatment before surgery

This means that having some treatment before surgery stopped 1 in 5 cancers coming back. There was still a benefit 5 years after treatment.

Problems after surgery
They also looked at how many people had problems after their operation. This included things such as:

  • an infection 
  • a leak where the ends of the colon are joined back together
  • needing to have a second operation
  • staying in hospital longer than expected 

These were all low in both groups. But they were lower in the group who had treatment before their operation.

Panitumumab
The team found that overall, chemotherapy and panitumumab didn’t work better than chemotherapy alone.

They plan to publish more results about this part of the trial at a later date. 

Conclusion
The trial team concluded that having some chemotherapy before and some after surgery is better than having all the chemotherapy afterwards. This is for people with bowel cancer that has not spread. 

They also concluded there was no extra benefit to having panitumumab as well as chemotherapy before surgery.

They suggest doctors should consider giving some chemotherapy before surgery for this group of patients.

More detailed information
There is more information about this research in the references below. 

Please note, these articles are not in plain English. They have been written for health care professionals and researchers.

FOxTROT: an international randomised controlled trial in 1052 patients (pts) evaluating neoadjuvant chemotherapy (NAC) for colon cancer.
M Seymour and others
Journal of Clinical Oncology, 2019. Volume 37, issue 15 supplement

Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial
D Morton and others
Journal of Clinical Oncology. Published online, January 2023. 

Where this information comes from    
We have based this summary on the information in the articles above. These have been reviewed by independent specialists (peer reviewed Open a glossary item) and published in medical journals. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Dion Morton

Supported by

Bobby Moore Fund (BMF)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/07/014.

There is more information about this and the other FOxTROT trials on the FOxTROT website.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

895

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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