A trial looking at chemotherapy followed by chemotherapy and radiotherapy together for locally advanced cervical cancer (CXII)

Who can enter

You can enter this trial if you

• Have stage 1b2, 2, 3 or 4a cervical cancer
• Are due to have chemoradiation for your cancer
• Are well enough for treatment (performance status 0 or 1)
• Have satisfactory blood test results
• Have a normal heart trace (ECG)
• Have normal kidney function
• Are at least 18 years old

You cannot enter this trial if you

• Have had another cancer in the past, apart from basal cell skin cancer
• Have a serious heart condition
• Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 50 patients. All people taking part will have chemotherapy followed by chemotherapy and radiotherapy at the same time (chemoradiation).

First of all you have paclitaxel (Taxol) and carboplatin on the same day, once a week for 6 weeks. You have them both through a drip into a vein. The paclitaxel takes about an hour, and the carboplatin about half an hour.

You then have cisplatin through a drip into a vein, once a week for up to 6 weeks. You also have radiotherapy once a day (Monday to Friday) for 5 or 6 weeks. So one day each week you will have cisplatin and radiotherapy on the same day.

Hospital visits

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

• Physical examination
• Blood tests
• Urine test
• MRI scan of your pelvis
• CT scan of your abdomen
• CT scan of your chest or a chest X-ray

You will also have an ‘examination under anaesthetic’ (EUA) so the doctors can thoroughly examine your cervix. They may also take a biopsy.

For the first part of the trial, you will go to the outpatient department once a week to have paclitaxel and carboplatin chemotherapy. You will be at the hospital for about half a day each time.

After that you will go to the hospital every day, Monday to Friday, for radiotherapy. Once a week you will also have cisplatin chemotherapy.

You will have blood tests twice a week while you are having treatment. You have an MRI scan of your pelvis at 6 weeks and 12 weeks (3 months). You may also have a CT scan of your abdomen at 3 months, but this will depend on the results of the scan you had before you started treatment.

You will see the doctors 4 weeks after you finish treatment, and then every 3 months for 2 years after that. You will have a physical examination and blood tests at each visit.

Side effects

The most common side effects of carboplatin and paclitaxel are

• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Feeling or being sick
• Hair loss
• Sore mouth
• Diarrhoea
• Numbness and tingling in hands and feet (peripheral neuropathy)

The most common side effects of cisplatin are

• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Feeling or being sick
• Reduced kidney function (you will have lots of fluids to stop this happening)
• Problems hearing high pitched sounds

The side effects of radiotherapy depend on the area of the body being treated. The most common short term side effects of radiotherapy for cervical cancer are

• Diarrhoea
• Bladder irritation (radiation cystitis)
• Feeling sick

You may also have long term side effects such as bladder or bowel problems, swelling in your legs (lymphoedema), or changes to your vagina, ovaries or womb.

But remember, not everyone will get every side effect. You may get very few.

There is more information about the side effects of carboplatin, paclitaxel (Taxol), cisplatin and radiotherapy for cervical cancer on CancerHelp UK.