FORT
Follicular Radiotherapy Trial
Introduction
Follicular lymphoma is a type of Non Hodgkin's lymphoma. The recommended treatment to control the symptoms of this
disease is radiotherapy. Radiotherapy is measured in units known as Gray (Gy). The total dose your doctor wants
you to have is then split into separate daily treatments know as fractions. Over the years a standard dose of
radiotherapy for advanced follicular lymphoma has been defined as 24 Gray over 12 fractions. That is, a total of
24 Gy split into 12 daily doses of 2Gy. However, there is growing evidence from trials such as this one that a
lower dose of a total of 4Gy over 2 daily doses of 2Gy is just as effective at controlling the cancer and causing
fewer side effects.
What is the aim of this trial?
This trial aims to find out whether low dose radiotherapy given over a short period of time is as effective as the
standard dose and schedule of radiotherapy in the treatment of people with advanced follicular lymphoma.
Who can enter this trial?
You may be asked to enter this trial if you meet the following criteria:
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You are aged between 18 and 65
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You have a follicular non-Hodgkin lymphoma
What might stop me from entering this trial?
You won't be asked to enter this trial for the following reasons:
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You have a type of non-Hodgkin lymphoma other than follicular non-Hodgkin lymphoma
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You have had chemotherapy within four weeks of the planned radiotherapy
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You are not well enough to have the radiotherapy
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You have Stage IA disease which needs to be treated radically with radiotherapy
Do I have to take part?
No. You are a key member of the health care team and it is completely up to you whether you want to be involved
in this trial. You have a right to say no or withdraw at any time without your ongoing care or treatment being
affected. If you do choose to take part you will be given lots of information and asked to sign a consent form.
How is this trial run?
This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with
similar disease traits are selected by a computer to be placed in different groups that are comparing different
treatments. There is no way at the time for researchers to know which of the treatments is best and neither you
nor your doctor get to choose which treatment you have.
In this particular trial there are two groups.
The first group
has standard radiotherapy. You will have treatment every day from Monday to Friday for 12 days.
Each treatment is called a fraction and the dose in each fraction is measured in Gray (Gy). You will receive 2 Gy
each day with an overall dose of 24Gy. This is usually given as 12 outpatient visits unless you need to stay in the
hospital for some reason.
The second group
has the lower dose radiotherapy. In this group you will have two treatments over two consecutive
days. Each treatment or fraction is measured as 2 Gy, with an overall dose of 4 Gray. This is usually given as 2
outpatient visits unless you need to stay in the hospital for some reason.
Regardless of which group you are in you will visit the radiotherapy department for planning of the radiotherapy.
Planning allows your health care team to work out exactly the parts of your body the radiotherapy is going to treat.
The team will put marks on your skin to ensure that exactly the same place is treated each time you have the
radiotherapy.
What might being entered in this trial mean to me?
Tests and hospital visits
Before you enter the trial you will have a number of tests to see how wide spread your disease is.
The investigations may include:
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A CT scan
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Blood tests
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Chest x-ray
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Physical examination
On completion of your radiotherapy treatment you will be seen by the doctor in a month. After that you will see
your doctor every three months for two years, then every six months for the next three years. After this schedule
of appointments is complete the doctor will see you once a year.
Side effects
As with other treatments there are some side effects which you should know about. Your doctor or nurse can give you
much more detailed information on these effects and how you might manage them.
Because radiotherapy is a localized treatment the side effects tend to relate to the part of the body receiving the
radiotherapy. For example, if you have radiotherapy to areas in the neck you may have a sore throat, or if the
radiotherapy is directed towards your stomach area you may feel sick or have some diarrhoea. However, regardless
of the site the most common side effects with radiotherapy are:
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You will probably feel very tired
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Your skin may get red and sore in the area being treated