Trial design

This is a randomised trial. It will recruit 1520 women into two groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group A you will have carboplatin and paclitaxel. You have both drugs through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is one cycle. You will have 6 cycles over 18 weeks (about 4 months).

If you are in group B, first you will have carboplatin, paclitaxel and bevacizumab through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is one cycle. You will have 6 cycles over 18 weeks (about 4 months). After that you have bevacizumab alone once every 3 weeks for another 12 cycles (nearly 9 months). So you have treatment for over a year altogether.

You will fill out a questionnaire before you start treatment, after each of the first 6 cycles of treatment, and after every other cycle after that (if you are in group B). It will ask you how you have been feeling and about any side effects you have had. It is called a quality of life questionnaire.

ICON7

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn 2nd Floor
London WC1V 6LJ

Email:
k.brown@ucl.ac.uk

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