A trial comparing the same dose with an increasing dose of carboplatin for ovarian cancer (SCOTROC 4)

Who can enter

You can enter this trial if you

• Have recently been diagnosed with epithelial ovarian cancer that is stage 0, 1, 2, or 3, fallopian tube cancer or non mucous producing ovarian type peritoneal cancer
• Are going to have carboplatin alone
• Are well enough to take part (performance status 0, 1 or 2)
• Have satisfactory blood test results
• Are at least 18 years old

You cannot enter this trial if you

• Have a mixed mesodermal tumour
• Have a borderline ovarian tumour
• Are due to have both carboplatin and paclitaxel (Taxol) chemotherapy
• Have had chemotherapy or radiotherapy before
• Had surgery more than 8 weeks ago
• Have had another cancer in the last 5 years, except for carcinoma in situ of the cervix, or basal cell skin cancer
• Have any other serious medical condition
• Have numbness and tingling in your hands and feet (peripheral neuropathy)
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 1,300 patients into 2 groups. People taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

Group 1 will have the same dose of carboplatin for each cycle. Group 2 will start at the same dose as group 1, but may have a higher dose of carboplatin each cycle.

You have carboplatin through a drip into a vein once every 3 weeks (1 cycle). It takes about an hour or so each time. You will have up to 6 cycles altogether over about 4 months (18 weeks).

You will fill in a questionnaire before you start treatment, before each cycle and after you finish treatment. It will ask how you are feeling and what side effects you are having. This is called a Quality of Life questionnaire.

If you have not had surgery, or if they were not able to remove all of your cancer with surgery before chemotherapy, you may have an operation after either 3 or 6 cycles of chemotherapy. This will be decided on an individual basis.

Hospital visits

You will have tests before you take part in the trial. These include

• Blood tests (including a test for CA125)
• Chest X-ray
• CT scan
• A biopsy
• Physical examination

The doctors will take another biopsy after 3 cycles of chemotherapy. You will have blood tests before each cycle, and once between each cycle to measure your blood cell counts. You will have a CA125 test before each cycle and after you finish treatment.

After you have finished chemotherapy, you will see the doctors

• Every 2 months for 2 years, then
• Every 3 months for a year, then
• Every 4 months for a year, then
• Every 6 months after that

You will have a physical examination and CA125 test at each visit.

Side effects

The most common side effects of carboplatin are

• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, shortness of breath or tiredness
• Loss of fertility
• Hair thinning
• Loss of appetite
• Altered taste

There is more information about carboplatin on CancerHelp UK.