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

This trial is looking at whether having some chemotherapy before surgery, and adding a drug called panitumumab (Vectibix), helps to stop or delay bowel cancer coming back. This trial is supported by Cancer Research UK.

Doctors usually treat bowel (colorectal) cancer with surgery. Many people also have chemotherapy after surgery (adjuvant therapy) to help stop the cancer coming back. We know from research that having adjuvant chemotherapy helps, but it doesn’t always stop the cancer coming back.

In this trial, the researchers are looking at giving some of the chemotherapy before surgery. This is called neoadjuvant treatment. It may make the cancer in the bowel smaller, so it is easier to remove completely. And if any of the cancer has already broken away and spread elsewhere in the body, it may be easier to get rid of it at this point than it is after surgery. 

Some of the people taking part in the trial will have a new drug called panitumumab. Panitumumab is a type of biological therapy called a monoclonal antibody. In earlier trials it has helped some people who have bowel cancer that has already spread. In this trial, the researchers want to find out if it would also help people who have bowel cancer removed by surgery.

Recent research has shown that panitumumab doesn’t help people who have bowel cancer with a change to a gene called K-RAS (a K-RAS mutation). So, the researchers will only ask you to join the part of the trial testing panitumumab if a test shows you have a normal K-RAS gene. If you do not agree to have the K-RAS test, you can still join the part of the trial comparing different ways of having chemotherapy.

The aims of the trial are to

  • Find out if having part of your chemotherapy as neoadjuvant treatment helps to stop or delay bowel cancer coming back
  • See if panitumumab and chemotherapy works better than chemotherapy alone for bowel cancer with a normal K-RAS gene that can be removed by surgery
  • Learn more about why the drugs help some people and not others

Recruitment

Start 01/04/2008
End 31/12/2015

Phase

Phase 3

Who can enter

You can enter this trial if you

  • Have been diagnosed with bowel (colorectal) cancer
  • Have a tumour that has grown at least 1mm outside the bowel wall or into nearby body organs (your doctor can advise you on this)
  • Have satisfactory blood test results
  • Are well enough to take part in the trial (performance status 0, 1 or 2)
  • Are willing to use reliable contraception if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have cancer that is close to your anus
  • Have cancer that your doctor thinks should be treated with radiotherapy
  • Have cancer that has spread elsewhere in your body through the lymphatic system or bloodstream
  • Have had any other cancer in the last 5 years apart from non melanoma skin cancer
  • Have an infection in your abdomen called peritonitis
  • Have bowel obstruction that has not been successfully treated
  • Have had a heart attack in the last 6 months
  • Have inflammatory bowel disease or angina that cannot be controlled with medicine
  • Have ever had interstitial pneumonitis or pulmonary fibrosis (these are both types of lung disease)
  • Have any other serious medical condition that could affect you taking part in the trial

Trial design

This is an international trial. It will recruit more than 1,000 people from around the world. Everybody taking part will have surgery to remove their bowel cancer and one of the following chemotherapy regimes

Everybody taking part will have chemotherapy. This is usually 24 weeks in total. But for some people, a shorter option of 12 weeks of treatment may be recommended by their doctor.

Most people have OxMdG chemotherapy in 2 week cycles of treatment. On day 1 of each cycle, you have the oxaliplatin and folinic acid through a drip into a vein over 2 hours. You then have an infusion of 5FU continuously over 46 hours. You have 12 cycles of treatment, lasting about 24 weeks in total. Or, if recommended by your doctor, 6 cycles of treatment, lasting 12 weeks in total.

Most hospitals can give you a portable pump so that you can go home with the 5FU infusion. But to use a pump, you also need to have a central line or a PICC line.

If you have OxCap, you have chemotherapy in 3 week cycles of treatment. On day 1 of each cycle, you have oxilaplatin as a drip into a vein over 2 hours. And then you take capecitabine tablets twice a day for 2 weeks (days 1 to 15 of the cycle). You have 8 cycles of treatment, lasting about 24 weeks in total. Or, if recommended by your doctor, 4 cycles of treatment, lasting 12 weeks in total.

As this is a randomised trial, the people taking part will be put into treatment groups by a random process. Neither you nor your doctor will be able to decide which group you are in.

Before you are put into a treatment group, the trial doctors need to find out if your cancer has a K-RAS gene mutation or not. With your permission, they will arrange to test a sample of the tissue taken when you had a biopsy. If tests show that you have a K-RAS mutation, you will only be put into group A or group C. If you have a normal K-RAS gene, you may be put into any of the groups.

People in group A will have 6 weeks of chemotherapy before surgery. The remaining 18 weeks of treatment (or 6 weeks if they have the shorter course of chemotherapy) will start between 4 and 8 weeks after their operation.

People in group B will have their chemotherapy in the same way as people in group A, but they will also have panitumumab for 6 weeks before surgery.

People in group C will have 24 weeks of chemotherapy (or 12 weeks if they have the shorter course) after their surgery. This will start between 4 and 8 weeks after their operation.

Please note - the first 150 people who take part in the trial will all have OxMdG chemotherapy. After that, some people may have the OxCap regime. But it is only people in group A or C who may be able to have OxCap.

If you are in group B, you will have panitumumab on the first day of each chemotherapy cycle for the first 6 weeks of treatment. Before your chemotherapy, you have the panitumumab as a drip into a vein. This takes about an hour.

As well as the sample used for K-RAS testing, the researchers will ask your permission to keep a sample of tissue removed when you have surgery to remove your bowel cancer. And they will ask you to have an extra blood test. They will study some of the genes in these samples to learn more about how they can affect the way people respond to the drugs and the side effects they have. If you do not want to give these extra samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Depending on the type of chemotherapy you have, you will go to hospital once every 2 or 3 weeks for treatment. You will have a blood test each time and the trial team will ask about any side effects you have had.

If you are in group A or B, you will have another CT scan between your pre surgery chemotherapy and your operation. The scan is to find out how well the chemotherapy treatment has worked and to see if it means you can have a smaller operation. If you do not want to have this extra CT scan, you don’t have to. You can still take part in the trial.

When you have surgery, you will be in hospital for about a week afterwards. You will then have a period of time at home to recover from your operation before you start (or continue) your chemotherapy.

After you finish your treatment, you will have regular follow up appointments for at least 3 years. You will occasionally have scans and blood tests.

Side effects

The most common side effects of oxaliplatin, 5FU and capecitabine include

There is more information about oxaliplatin, 5FU and capecitabine in our Cancer drugs section.

The possible side effects of panitumumab include

  • Rash
  • Soreness around your nails and the tips of your fingers and toes
  • Loss of appetite
  • Tiredness
  • Feeling anxious or short of breath
  • Aching muscles
  • Swelling in the hands or feet

As with any new treatment, it is possible that there could be some side effects the doctors don’t know about yet.

Location of trial

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Prof Dion Morton

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

Supported by

Bobby Moore Fund (BMF)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
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Updated: 3 June 2014