A study to find the best way to give radiotherapy for people with small cell lung cancer (CONVERT)

You can enter this trial if you

• Have been diagnosed with small cell lung cancer
• Have lung cancer that could be treated with radical radiotherapy
• Are well enough to take part (performance status 0 or 1)
• Are well enough to have chemotherapy and radiotherapy
• Have satisfactory lung function test results
• Have satisfactory blood test results
• Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant
• Are able to come to all your trial appointments
• Are 18 years or older

You cannot enter this trial if you

• Have had any cancer except carcinoma in situ of the cervix, non melanoma skin cancer or another cancer (except breast cancer) that was removed and has been clear for at least 5 years
• Have already had surgery for lung cancer
• Have already had radiotherapy for lung cancer
• Have fluid around your heart or lungs (pericardial or pleural effusions) caused by your cancer
• Have any other serious illness that may affect the results of the trial
• Are pregnant or breastfeeding

This trial will recruit 532 patients over 4 years. This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone in the trial will have cisplatin and etoposide chemotherapy. These are standard chemotherapy drugs for small cell lung cancer. You will have your chemotherapy through a drip into a vein, on the first 3 days of every 3 week cycle of treatment. You will have up to 6 cycles of chemotherapy altogether. You will begin radiotherapy 3 weeks after your first cycle of chemotherapy. You can talk to your doctor more about your chemotherapy.

If you are in group 1, you will have radiotherapy twice a day, Monday to Friday, for 3 weeks. You will have a gap of around 6 to 8 hours between your treatments each day. The radiotherapy itself will take about 15 minutes per treatment.

If you are in group 2, you will have radiotherapy once a day, Monday to Friday, for 6 and a half weeks.

The research team will also ask for your permission (consent) to store a sample of cancer tissue removed during your surgery, and some extra blood samples. This tissue and blood will be used in future research into small cell lung cancer. You will have the extra blood samples taken at the same time as other blood tests.

After you have completed the radiotherapy and chemotherapy to your chest, your doctor may offer you a short course of radiotherapy to your brain. This is to help prevent your lung cancer spreading to your brain. If your doctor thinks this is appropriate for you they will explain more about this treatment.

Before you start the trial, you will see the doctor and have some tests. These tests include

• Chest X-ray
• CT scan of your brain, chest and tummy area (abdomen)
• A radiotherapy planning scan
• Lung function tests
• Blood tests
• Bone scan (if needed)
• Pregnancy test (if appropriate)

Everyone will have between 4 and 6 cycles of chemotherapy, depending on what their doctor has prescribed. So your chemotherapy could last between 12 and 18 weeks. You will have your chemotherapy and radiotherapy as an outpatient.

Before each cycle of chemotherapy, you will see the doctor and have a blood test. As part of the trial, you will also have a chest X-ray before your first cycle of chemotherapy, and before alternate cycles after this.

If you are in group 1, you will start your course of radiotherapy on the first day of your second cycle of chemotherapy. Your radiotherapy will last for 3 weeks. You will then have more chemotherapy every 3 weeks until you have finished your course.

If you are in group 2, you will also start your radiotherapy at the same time as your second cycle of chemotherapy. Your radiotherapy will continue for 6 and a half weeks. You will continue to have your remaining cycles of chemotherapy during this time.

During your radiotherapy, you will see the doctor weekly for a check up while you are in for your treatment. You will have a CT scan when you finish your treatment, and 6 months later. You will also see the trial team every week after the study until any symptoms have cleared up. You will then see the team every

• 3 months for one year
• 6 months after this

After the trial has finished, you will continue to see you own doctor as you did before.

Common side effects of cisplatin and etoposide chemotherapy include

• Feeling or being sick
• Diarrhoea
• Constipation
• Sore mouth
• Loss of appetite
• Hair loss
• Feeling very tired (fatigue)
• Numbness and tingling in your hands and feet (peripheral neuropathy)
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Possible loss of fertility
• Your kidneys working less well - it is important to drink plenty of fluid before and after your chemotherapy

You can find out more about cisplatin and etoposide chemotherapy on CancerHelp UK.

Common short term side effects of radiotherapy include

• Temporary pain in your chest
• Coughing and bringing up spit (sputum)
• Tiredness
• Difficulty in swallowing
• Shortness of breath
• Skin rash

Possible late (delayed) side effects of radiotherapy for lung cancer include

• Narrowing of your food pipe
• Shortness of breath caused by scarring (fibrosis) of your lungs
• Thinning of the bones in the area you had your radiotherapy, possibly affecting your ribs or spine (this is very rare)

You may have a small bruise where you had your blood test.