Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at either pemetrexed or etoposide with cisplatin and radiotherapy for locally advanced non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing a combination of pemetrexed, cisplatin and radiotherapy with a combination of etoposide, cisplatin and radiotherapy for non small cell lung cancer (NSCLC) that is
More about this trial
If it is not possible to have surgery to remove NSCLC, you may have treatment with radiotherapy and chemotherapy. Doctors don’t yet know which combination of chemotherapy drugs works best in this situation, but usually it includes a
In this trial, the researchers are comparing a drug called etoposide with a drug called pemetrexed. Whichever drug you have, you also have cisplatin and radiotherapy.
The aims of the trial are to
- Find out which treatment works best for locally advanced non small cell lung cancer
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have non small cell lung cancer that is stage 3A or 3B and cannot be removed with surgery
- Have satisfactory
lung function testresults
- Have satisfactory blood test results
- Are well enough to take part in the trial
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months after if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have a tumour in which most of the tissue is
squamous cell cancer(your doctor will advise you about this)
- Have already had chemotherapy for lung cancer
- Have a pleural effusion or a build up of fluid around the heart (pericardial effusion)
- Have had radiotherapy to your chest, to more than a quarter of your
bone marrow, or to all of your pelvis
- Have had radiotherapy in the last month or have not recovered from the side effects of earlier treatment
- Have lost more than 5% of your body weight in the last 3 months
- Have hearing loss
- Have had a heart attack in the last 6 months
- Have another serious medical condition that cannot be controlled with medication
- Have had an experimental treatment as part of another clinical trial in the last month
- Have had a yellow fever vaccination in the last month
- Have ever had breast cancer or melanoma
- Have had any another cancer in the last 5 years apart from non melanoma skin cancer or
carcinoma in situthat has been successfully treated
- Take a high dose of aspirin or another non steroidal anti inflammatory drug and you cannot stop taking it for a few days at a time (you should not stop taking any regular medication without talking to your doctor first)
- Are unable to take steroids
- Are known to react to pemetrexed, cisplatin or etoposide
- Are HIV positive or if your
immune systemdoes not work well for any other reason
- Are pregnant or breastfeeding
This is an international trial that will recruit about 600 people around the world. It is a randomised trial. The people taking part will be put into one of 2 groups by computer. Neither you nor your doctor can decide which group you are in.
If you are in group A, you have pemetrexed and cisplatin through a drip into a vein every 3 weeks. Each 3 week period is called a cycle of treatment. You have 3 cycles of this treatment, then a rest period of between 3 and 5 weeks, followed by 4 more cycles of treatment with pemetrexed alone. To help control the side effects of pemetrexed, you take a steroid tablet called dexamethasone each time you have it. You also have folic acid tablets, and vitamin B12 injections.
On day 1 of the first cycle of chemotherapy treatment, you will also start radiotherapy. You have radiotherapy each day from Monday to Friday for just over 6 weeks.
If you are in group B, you start having chemotherapy in 4 week cycles of treatment. You have etoposide through a drip into a vein on the first 5 days of each cycle. And you have cisplatin on the 1st and 8th day. You have 2 cycles of treatment, then a rest period of between 3 and 5 weeks, followed by 2 more cycles of treatment. For these last 2 cycles of treatment, doctors are looking at different chemotherapy drugs. You may have one of the following
- Etoposide and cisplatin in 4 week cycles (the same as the first 2 cycles)
- Vinorelbine and cisplatin in 3 week cycles
- Paclitaxel and carboplatin in 3 week cycles
Your doctor will decide which combination you have. You will have the drugs through a drip into a vein.
You start radiotherapy on day 1 of the first cycle of chemotherapy. You have it each day from Monday to Friday for just over 6 weeks.
Everybody taking part will be asked to fill in a diary once a week to record whether or not you have had any problems swallowing.
You will see the doctors and have some tests before you start treatment. The tests include
You have to go to hospital every day for about 6 weeks to have radiotherapy. In most hospitals you have treatment from Monday to Friday with a break at the weekends. On some days you will also have chemotherapy. The number of hospital visits you have after your radiotherapy has finished will depend on the type of chemotherapy you have.
You see the doctors and have blood tests regularly during your treatment. After you finish treatment you will see the doctors every 3 months for up to 5 years.
You will have a number of scans during your treatment and a month after finishing treatment. Then you have a scan
- After 6, 9 and 12 months
- Every 4 months in the next year
- Every 6 months in the following year
The side effects of the chemotherapy drugs in this trial include
- A drop in the number of blood cells causing an increased risk of infection, tiredness, breathlessness, bruising or bleeding problems
- Diarrhoea or constipation
- Hair loss
- Sore mouth
- Skin rash
- Swelling of the limbs or face caused by a build up of fluid
- Abdominal (tummy) pain
- Fever or chills
- Weakness and fatigue
- Breathing problems or cough
- Loss of appetite
- Kidney damage
This list is for all the drugs in the trial. Not everyone gets every side of a drug and nobody will have all the drugs.
Having radiotherapy and chemotherapy at the same time can mean that side effects such as difficulty swallowing are worse, or that they last longer.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mayukh Das
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer