This is an international
phase 3 trial. Researchers hope that around 854 people worldwide and about 70 people from the UK will agree to take part.
It is a
randomised trial. Everyone taking part is put into 1 of the following treatment groups by computer:
- S 95005 and bevacizumab
- capecitabine and bevacizumab
Neither you nor your doctor can choose which group you are in.
S 95005 and bevacizumab
Everyone has S95005 and bevacizumab in
cycles of treatment that last 4 weeks. The first day of each cycle is called day 1.
You take S 95005 as tablets that you swallow whole, twice a day. You should take them within 1 hour after your breakfast and dinner.
You have S 95005 and bevacizumab in the following way:
- you take S 95005 twice a day on days 1 to 5 and days 8 to 12
- you have bevacizumab on day 1 and day 15
- you have no treatment on days 15 to 28
You then start a new cycle of treatment. This continues for as long as treatment is helping you and the side effects aren’t too bad.
Capecitabine and bevacizumab
You have capecitabine and bevacizumab as cycles of treatment that last 3 weeks.
You take capecitabine as tablets that you swallow whole, twice a day. You should take them within 30 minutes after your breakfast and dinner. And have bevacizumab as a drip into your bloodstream.
You have each cycle of treatment in the following way:
- you have bevacizumab on day 1
- you take capecitabine tablets twice a day on days 1 to 14
- you have no treatment on days 15 to 21
You then start a new cycle of treatment. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
Quality of life questionnaires
- every 6 weeks during treatment
- after you finish treatment
The questionnaires ask about how you are feeling and the side effects you might have. You complete the questionnaires on a tablet (electronically) when you are at the hospital.
Blood samples
You might have an extra blood test before the start of your treatment. Doctors want to look for a protein called BRAF that can help to tell how well treatment might work (BRAF status).
You don’t have to have an extra blood test if doctors already know your BRAF status.