A trial looking at radiotherapy with Tarceva for lung cancer that has spread to the brain (TACTIC)

Please note this trial is no longer recruiting patients.

This study is looking at radiotherapy to the brain combined with a new biological therapy called Tarceva (erlotinib) as a treatment for non small cell lung cancer (NSCLC) that has spread to the brain.

If lung cancer spreads to the brain (secondary brain cancer), doctors may suggest treatment with radiotherapy to shrink the cancer and help control it. Doctors are keen to find out if combining radiotherapy with Tarceva improves this treatment.

In the body there are substances called growth factors that encourage cells to grow. Growth factors work by latching on to receptors on the surface of the cell. These are called ‘epidermal growth factor receptors’. Tarceva works by blocking these receptors. Doctors hope that by blocking the receptors they will be able to stop or slow down the growth of cancer cells.

In this trial, people with non small cell lung cancer that has spread to the brain will either have

Radiotherapy to the brain and Tarceva
Radiotherapy to the brain and a dummy tablet (placebo)

The aim of the trial is to find out if Tarceva combined with radiotherapy to the brain is a better treatment than radiotherapy on its own. And to find out more about the side effects of the treatment.

Recruitment

Start 06/01/2008

End 04/06/2010

Phase

Phase 2

Who can enter

You can enter this trial if

You have non small cell lung cancer (NSCLC)
Your cancer has spread to more than one area of your brain OR
Your cancer has spread to just one area of your brain, but you are not able to have surgery or stereotactic radiosurgery
Your doctors do not expect you to need chemotherapy for at least 2 months after this trial radiotherapy
Your doctor thinks that radiotherapy to the brain will help you
You have satisfactory blood tests
You are able to swallow and keep down medicines
You are well enough to take part (performance status 0, 1 or 2)
You are prepared to use reliable contraception while you are taking part in the trial, if there is any chance you or your partner could become pregnant
You are more than 18 and less than 76 years old
You have access to a telephone
You have a carer willing to help you to take part in the trial

You cannot enter this trial if

You do not have non small cell lung cancer
Your cancer has spread to 4 or more different areas of the body (this does not include the area of the lung where your cancer first started or the brain)
You are having moderate or severe symptoms from your secondary brain cancer (the doctors will be able to tell you more about this)
You only have one area of cancer in your brain, and you are able to have surgery or stereotactic radiosurgery
Your doctor thinks that radiotherapy to the brain will not help you or is not sure that it will help
Your doctor thinks you need chemotherapy straight away to help control symptoms
You have had radiotherapy, radiosurgery or chemotherapy for secondary brain cancer in the past
You have had chemotherapy in the last 4 weeks
You have had treatment with a drug similar to Tarceva in the past (an EGFR inhibitor)
You have kidney or liver problems
You have another medical condition which is not under control
You have had any other cancer in the past that the researchers think will affect your treatment, or the results of this trial
You are taking drugs called Cox-2 inhibitors
You are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 80 people into two groups. The people taking part are put into the groups by a computer. Neither you nor your doctor will be able to decide which group you are in or will know which group you are in. This is called a double blind trial.

If you are in group 1, you will have radiotherapy to the brain and take Tarceva.

If you are in group 2, you will have radiotherapy to the brain and take a dummy tablet (placebo).

Everyone taking part will have radiotherapy to the whole brain once a day, for 5 days. You will start taking Tarceva or the placebo in the morning of your first radiotherapy treatment. You will take Tarceva or the placebo tablet by mouth once a day, for up to 2 years. Exactly how long you take the Tarceva or placebo will depend on how you are and on the side effects you have.

The researchers would like to look at the sample of your cancer that the hospital will have kept from your biopsy or surgery. This will help them find out more about any genetic changes in the cancer cells, and how this affects cancer or Tarceva.

You will be asked to fill in questionnaires as part of this trial. These are called quality of life questionnaires. They will ask how you have been feeling and about your symptoms. You will fill in the questionnaires

Before you start the treatment
Every month for the first year
Every 6 months for the second year

Hospital visits

Before you can join this trial, you will need some tests. These include

Blood tests
Chest X-ray
CT scan or MRI scan

The doctors would like to take an extra blood sample before you start treatment. They will use this to look at your genes to see if these affect how well Tarceva works.

You will go to the hospital every day for 5 days to have radiotherapy. You can read more about having radiotherapy for secondary brain cancer on CancerHelp UK.

You will see the doctor every 2 weeks for the first 2 months, and then once a month for as long as you are taking Tarceva or the placebo. When you stop taking the tablets you will see the doctors every 2 months.

You will have a chest X-ray every month. And you will have another CT scan or MRI scan about 2 months after you start treatment. The doctors may repeat these scans later on in the study.