A trial to find the best timing for radiotherapy and chemotherapy for advanced non small cell lung cancer (SOCCAR)

Who can enter

You can enter this trial if you

• Have stage 3 non small cell lung cancer (NSCLC) that cannot be removed with an operation
• Are well enough for treatment (performance status 0 or 1)
• Have satisfactory blood test results
• Are prepared to use reliable contraception while you are taking part in this trial
• Are at least 18 years old

You cannot enter this trial if you

• Have non small cell lung cancer that is not stage 3
• Have fluid around the lungs caused by your lung cancer (a malignant pleural effusion)
• Have had chemotherapy or radiotherapy for your lung cancer before
• Have any other serious medical condition
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. There are 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

If you are in group 1 you will have a course of chemotherapy followed by a course of radiotherapy. This is called sequential treatment. You will have chemotherapy in 3 week cycles. You have cisplatin and vinorelbine (Navelbine) through a drip into a vein on the first day, vinorelbine alone a week later (day 8), and then no chemotherapy for 2 weeks. You will have up to 4 cycles over 3 months (12 weeks).

Three to four weeks after your last dose of chemotherapy you will start radiotherapy. You will have 20 treatments (called fractions) - one a day, 5 days a week (Monday to Friday) for 4 weeks. So you will have treatment for about 4 and a half months (18 weeks) altogether.

If you are in group 2 you will have your course of chemotherapy at the same time as your radiotherapy. This is called concurrent treatment. You will have 20 fractions of radiotherapy, one a day, five days a week for 4 weeks. You will have vinorelbine or cisplatin through a drip into a vein on 11 of the 20 days that you have radiotherapy. On the days that you have both treatments, you will have chemotherapy first, and then radiotherapy.

If you are in group 2, you will have up to two further 3 week cycles of chemotherapy 4 weeks after you finish concurrent radiotherapy and chemotherapy. You have vinorelbine and cisplatin on day 1, vinorelbine again on day 8 and then no chemotherapy for 2 weeks. You will have 2 cycles over 6 weeks. So you will have treatment for about 3 months (12 weeks) altogether.

Hospital visits

You will have some tests before you start the trial. These include

• Blood tests
• Heart trace (ECG)
• CT scan
• Lung function tests
• Physical examination

You will have most of your chemotherapy and radiotherapy as an outpatient. You may stay in hospital overnight when you start chemotherapy if you have sequential treatment. Or for a few nights each time you have concurrent treatment.

You will have blood tests every week. And a CT scan after about 3 months and 6 months. When you start the trial you will see the doctors roughly

• Every 3 weeks for 4 months, then
• Every month for another 2 months, then
• Every 3 months for 18 months, then
• Every 6 months for a year and then
• Once a year after that

Side effects

The most common side effects of vinorelbine and cisplatin are

• Constipation
• Feeling or being sick
• Drop in blood cells causing an increased risk of infection, bleeding or bruising problems, shortness of breath and tiredness
• Loss of fertility
• Pain along the vein used for vinorelbine
• Darkening or discolouration along the vein used for your vinorelbine drip
• Kidney damage with cisplatin

The most common side effects of radiotherapy to the lung are

• Tiredness
• Sore skin
• Sore throat and difficulty swallowing
• Cough

There is more information about vinorelbine, cisplatin and radiotherapy for lung cancer on CancerHelp UK.