A trial to find out if dalteparin can improve treatment for lung cancer (FRAGMATIC)

This trial is looking at a blood thinning drug called dalteparin (also called Fragmin) to see if it can reduce the number of blood clots people have during treatment for lung cancer. And to find out if it can help to stop cancer cells spreading through the bloodstream to other parts of the body.

Doctors treat lung cancer with surgery, chemotherapy or radiotherapy. You may have more than one of these treatments. Your doctor will plan the best treatment for you, depending on the type of lung cancer you have, the stage of the disease and your general health.

Blood clots are quite common in people who have lung cancer. And cancer treatment can increase the risk of blood clots. Dalteparin is a blood thinning drug (anticoagulant) that is widely used to prevent and treat blood clots. Doctors think that dalteparin may also affect how cancer cells spread through the bloodstream, but they don’t know this for sure.

The aims of this trial are

To see if having dalteparin as well as standard treatment is better than having standard treatment alone for lung cancer
To see if people having dalteparin injections have fewer blood clots than people who don’t have the injections
To learn more about the side effects of having regular dalteparin injections at the same time as standard treatment for lung cancer

Recruitment

Start 01/08/2007

End 01/08/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with lung cancer in the last 6 weeks
Are well enough to take part in the trial (performance status 0, 1, 2 or 3)
Are willing and able to give yourself a small injection each day (or you are happy for a relative or carer to do this for you)
Are willing to use a reliable form of contraception during the trial if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have lung cancer that has spread to your brain
Have secondary lung cancer, carcinoid, mesothelioma or lymphoma
Have had any other cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated or another cancer that has been in complete remission for at least 5 years
Have had any other treatment that is likely to affect the results of the trial (the trial doctor will advise you on this)
Are bringing up a lot of blood when you cough
Have a low platelet count
Have kidney problems
Have had a stroke in the last 3 months
Have problems with your blood clotting properly
Have had any blood thinning (anticoagulant) drugs in the last 12 months
Are sensitive to dalteparin or other types of heparin
Take an anti inflammatory drug called ketorolac (Toradol)
Are pregnant or breast feeding

Trial design

This is a randomised trial. It will recruit over 2,000 people in the UK. Everybody taking part in the trial will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have standard treatment for lung cancer.

If you are in group 2, you will have standard treatment for lung cancer and a dalteparin (Fragmin) injection once a day for 24 weeks. The injections will start as soon as possible after you join the trial and before you start your other cancer treatment.

The trial team will show you how to give yourself the injections. If you are not going to do it yourself, they will teach your relative or carer. Each injection comes in a syringe that is ready to inject. It contains a very small amount of fluid and you inject the short, thin needle just under the skin.

The doctors will ask everybody taking part to fill in 3 questionnaires at the beginning of the trial and then every 3 months for a year. These will ask you about any side effects you have and how you have been feeling. This is called a quality of life study.

Hospital visits

You will go to the hospital to see the doctor and have some tests before you take part in the trial. These include

Physical examination
Bronchoscopy
CT scan
Chest X-ray
Blood tests

Everybody taking part will go to see the doctors (or speak to them on the telephone) at least once during the first 2 weeks of treatment. And you will have an extra hospital appointment every 3 to 4 weeks for 24 weeks. You will have blood tests at each visit.

After that, you will see the doctors every 12 weeks for up to a year. And you will continue to have follow up appointments with the trial team for at least 2 years after you finish treatment.

Side effects

The side effects of dalteparin include

Bleeding or bruising
Low platelet count
Rash
Fever
A reaction at the injection site
Osteoporosis (thinning of the bones)

The trial team will monitor you closely for any side effects during the trial and will tell you to stop the injections if necessary. You may be able to start the injections again if any side effects get better.