A trial looking at different treatments for different types of bowel cancer (FOCUS4)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Open

Phase:

Phase 2/3

This trial is testing different treatments for different subtypes of bowel cancer. The trial is for bowel cancer that cannot be removed with surgery or has spread to another part of your body.

If bowel cancer cannot be completely removed with surgery, or has spread to another part of your body, you are likely to have chemotherapy. We know from research that for most people it is safe to have a break from chemotherapy after a few months.

In this trial, researchers want to see if having other treatment during this chemotherapy break helps to extend the time before bowel cancer starts growing again. Not all bowel cancers are the same and some new cancer drugs may help people with one type of bowel cancer more than another.

To work out the subtype of bowel cancer you have, the researchers will test a sample of your cancer to look for changes to certain genes and proteins that your tumour produces.

If you agree to have a sample of your cancer tested, and your cancer doesn’t get any bigger during chemotherapy, you can enter the part of the trial testing new treatments. The researchers will look at a number of different treatments. They call these comparisons.

Please note – at present, only 2 of the comparisons are recruiting people. These are called FOCUS4-D and FOCUS4-N.

Who can enter

You may be able to join this trial if you

  • Have a type of cancer called adenocarcinoma that started in the large bowel (colon) or back passage (rectum)
  • Have cancer that cannot be removed with surgery or has spread to another part of your body
  • Have cancer that can be measured on a scan, and a sample of your cancer taken before you started chemotherapy can be tested to look for proteins and gene changes
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Had a CT scan in the 6 weeks before you started chemotherapy and the results of the scan are available electronically
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant

As well as the above, to enter the comparison called FOCUS4-D, the following must also apply

  • Your cancer must have normal B-RAF, PIK3CA, K-RAS and N-RAS genes
  • It must be at least 3 weeks since your last dose of chemotherapy or biological therapy
  • Your heart must be working well – you have an echocardiogram Open a glossary item or MUGA Open a glossary item scan to test this
  • Your cancer must have stayed the same size, got smaller or completely disappeared after having 16 weeks of chemotherapy, and you have had a CT scan in the last 4 weeks that confirms this

To enter comparison FOCUS4-N, your cancer must have stayed the same size or got smaller after having 16 weeks of chemotherapy and you have had a CT scan in the last 28 days that confirms this.

You cannot join any part of the trial if you

As well as this, you can’t enter FOCUS4-D if you

  • Are known to be very sensitive to drugs called tyrosine kinase inhibitors
  • Still have side effects such as diarrhoea, sore mouth, skin changes or eye problems following other treatment, unless they are only mild
  • Have an infection or swelling (inflammation) in your eyes, or have certain other eye problems (the trial team can advise you about this)
  • Have certain heart problems (the trial team can advise you about this)
  • Have already had large amounts of chemotherapy drugs called mitoxantrone, doxorubicin or epirubicin (the trial team can advise you about this)
  • Need to carry on taking other medication that can affect your heart rhythm or body substances called CYP enzymes (the trial team can advise you about this)
  • Have had swelling of your lungs caused by radiotherapy (radiation pneumonitis) or a lung condition called interstitial lung disease
  • Have skin problems called acne rosacea, psoriasis or atopic eczema

And you can’t enter FOCUS4-N if you

  • Can’t take capecitabine for any reason
  • Are going to have a combination of chemotherapy and radiotherapy for rectal cancer (you can take part if you’re having radiotherapy for symptoms)
  • Have high blood pressure that can’t be well controlled or certain heart problems (the trial team can advise you about this)
  • Are taking part in any other trial looking at treatment for people in your situation

Trial design

The researchers aim to recruit more than 1,500 people at hospitals across the UK. To start with, you have up to 16 weeks of chemotherapy. If you have already started chemotherapy, you can join the trial up until the 12th week of your chemotherapy treatment.

While you are having chemotherapy, the researchers will test a sample of cancer that was taken when you had surgery or a biopsy Open a glossary item to diagnose it. They will try to classify your cancer as a particular subtype. In about 2 out of 100 people (2%), it is not possible to classify the tumour as a specific bowel cancer subtype.

At the moment, the trial aims to test treatments in 4 different subtypes of bowel cancer.

  • The comparison called FOCUS4-A is for cancer with a change (mutation) to a gene called B-RAF
  • The comparison called FOCUS4-B is for cancer with a change to a gene called PIK3CA or that only produces a small amount of a protein called PTEN
  • The comparison called FOCUS4-C is for cancer with a change to genes called K-RAS or N-RAS
  • The comparison called FOCUS4-D is for cancer that doesn’t have changes to any of these genes
  • The comparison called FOCUS4-N is for cancer that cannot be classified as any of the subtypes above

Each comparison is randomised. You are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

FOCUS 4 trial diagram

Please note – at the moment, people are only being recruited into the comparisons called FOCUS4-D and FOCUS4-N.

If you have cancer that is classified as a subtype suitable for comparison A, B or C, until these comparisons are open to recruitment, you can choose to join FOCUS4-N. You can also join FOCUS4-N if you don’t want to travel to a cancer centre Open a glossary item to have treatment in one of the other comparisons, or if you would just prefer to join this comparison.

Comparison FOCUS4-D is looking at a drug called AZD8931 which is a type of biological therapy. It works by blocking certain proteins on cancer cells that send signals telling cancer cells to divide. If you join this comparison, you will have 1 of the following

  • AZD8931tablets twice a day
  • Dummy tablets (placebos Open a glossary item) twice a day

Neither you nor your doctor will know which tablet you are having. This is called a double blind trial.

As long as you don’t have bad side effects, you carry on treatment for as long as it helps you. If there are signs that your cancer is starting to grow again, you stop taking AZD8931 (or the dummy tablets). The trial doctor will talk to you about restarting chemotherapy or starting a different treatment.

Comparison FOCUS4-N is looking at the chemotherapy drug capecitabine. If you join this comparison, you will have 1 of the following

  • No further treatment until scans show your cancer is beginning to grow again (active monitoring)
  • Capecitabine tablets twice each day for 2 weeks out of every 3

If you are in the active monitoring group and there are signs that your cancer is starting to grow again, the trial doctor will talk to you about restarting chemotherapy or starting a different treatment. If you are having capecitabine and there are signs that your cancer is starting to grow again, you stop taking the tablets. The trial doctor will talk to you about restarting chemotherapy or starting a different treatment.

Hospital visits

When you join the trial, the researchers will test a sample of your cancer that had already been removed. But they will ask you to consider having 2 new biopsies Open a glossary item to compare with the sample that has already been tested. They will want to get a new biopsy sample before you start one of the trial treatments and another one at the end of the trial treatment. These biopsies are optional. If you don’t want to give these samples for research, you don’t have to. You can still take part in the main trial.

You see the trial team and have blood tests regularly during the trial. How often you go to hospital, and the tests you need to have depends on which group you are in.

If you are in FOCUS4-D, you have either an echocardiogram Open a glossary item or MUGA Open a glossary item scan to test your heart before starting treatment. You have the same test again after 8 weeks. You see the trial team every 4 weeks. You have a CT scan every 8 weeks. You have eye tests before treatment and then every 4 weeks if you have new problems with your eyes.

If you are in FOCUS4-N, you see the trial team every 3 to 4 weeks and have a CT scan every 8 to 9 weeks.

The trial team will ask people who join FOCUS4-N to fill out a questionnaire before they start treatment, every 8 weeks during treatment and after they finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Whichever comparison you join, when you finish the trial treatment, you see the trial team again within 4 weeks, then after 3 months and then every 6 months after that.

Side effects

As AZD8931 is a new drug, there may be side effects we don’t know about yet. In other trials, the side effects have included

People who have had drugs that work in a similar way to AZD8931 have had side effects such as

  • Problems swallowing
  • Feeling or being sick
  • Heartburn or indigestion
  • Feeling breathless or tired
  • Swollen feet or ankles
  • Palpitations
  • Cough

The side effects of capecitabine include

Occasionally, it can also cause some chest pain. We have more information about side effects of capecitabine.

Location

Aberdeen
Bangor
Basingstoke
Bath
Birmingham
Boston
Bournemouth
Bristol
Bristol
Cardiff
Carmarthen
Cheltenham
Chesterfield
Cottingham
Crewe
Dorchester
Dudley
Dundee
Edinburgh
Forth Valley
Glasgow
Gloucester
Guildford
Halifax
Harlow
Haverfordwest
Huddersfield
Huntingdon
Leeds
Leicester
Lincoln
London
Macclesfield
Maidstone
Manchester
Newcastle upon Tyne
Northampton
Northwood
Nottingham
Oxford
Peterborough
Poole
Rhyl
Rotherham
Sheffield
South Shields
Southampton
Sutton
Swindon
Taunton
Wakefield
Weston Super Mare
Wigan
Winchester
Wirral
Wrexham
Yeovil

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 Tim Maughan
Dr Richard Wilson

Supported by

AstraZeneca
Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
NIHR Efficacy and Mechanism Evaluation (EME) Programme
University College London (UCL)
University of Belfast
University of Leeds
University of Oxford

Other information

The Trial is funded jointly by Cancer Research UK and the Medical Research Council (MRC)/National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme.

This is Cancer Research UK trial number CRUK/11/054.

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

 

Last review date

CRUK internal database number:

9181

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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