Clinical trials for pancreatic cancer
This section contains information about the clinical trials
currently running for pancreatic cancer in the UK. It aims to
provide information to patients, carers and families about trials
that you may be able to take part in.
Introduction to the clinical trial information
This introductory page contains background information to help
explain the information provided in the individual
trial summaries. Each trial summary contains information on the
full name of the trial, the phase of the trial, a summary of who
the trial may be suitable for, where in the country the trial is
taking place and the recruitment start and finish dates.
You can use this information to discuss with your doctor(s)
whether or not you might be entered into a trial if there is a
suitable one at your local hospital or near enough for you to be
referred to a different hospital.
What are clinical trials?
Clinical trials are medical research studies that involve
patients. They go on in all areas of medicine and are the only way
for researchers and doctors to find out whether a new approach to
treatment or care is better than a current one.
Clinical trials have to be completely thorough to ensure that
new treatments are safe and effective. This means there can often
be years between a new drug being tested in the laboratory and it
being widely prescribed for patients. Trials don't always result in
new or better treatments; sometimes a new drug doesn't work or has
bad side effects. Such information is still helpful for researchers
and doctors, and patients too.
For cancer, clinical trials look at new treatments, better ways
of giving existing treatment or controlling treatment side effects.
They also look at cancer risk and prevention, screening and
diagnosis - in fact all aspects of the disease. Most trials in
pancreatic cancer are looking at different treatment options with
the aim of finding more effective treatments to improve survival
and quality of life.
Clinical trials, for example for a new drug, begin with an idea
being thoroughly tested in a research laboratory. If the results
are positive the trial plan then has to be approved by independent
scientists and by the participating hospital's ethics committee
before patients can start to be recruited. (An ethics
committee is made up of health professionals and lay members and is
responsible for protecting the rights, safety and wellbeing of
research participants).
Different types of trial
Clinical trials related to treatment generally have four
different stages, known as phases. (Roman numerals are most
commonly used for the different phases although numbers can also be
used.)
Phase I trials
These are the first stage in testing a new treatment and only
involve a very small number of patients, sometimes with different
types of cancer. The aim is to find out the safe dose of a drug,
what the side effects might be, how well the body tolerates the
drug and whether it has an effect on the cancer.
Most often patients who join phase I trials have advanced cancer
and no other treatment options available. While these patients may
not benefit directly from the trial it is still an important step
towards finding new treatments for future patients.
Phase II trials
A phase II trial usually involves larger numbers of patients and
only takes place if the results from phase I are positive. The aim
is to find out whether the new treatment works well enough to test
it in an even bigger trial (phase III), as well as more information
about the best dose to use and about the side effects and how to
manage them. At this state, the trial may still be for more than
one type of cancer, in which case it will look at which types of
cancer the treatment works for.
Sometimes phase II trials compare a new treatment with an
existing one or with a dummy drug (placebo). Again, if the results
are positive the trial moves to phase III.
Phase III trials
Phase III trials compare new treatments with the best treatment
currently available, for example by directly comparing the new
treatment with the existing one or comparing different doses or
ways of giving treatment. They usually recruit far more patients,
sometimes thousands, often in many different hospitals and even in
a number of different countries. These large numbers are needed so
that even small differences in results can be seen more easily.
Phase III trials are usually randomised. This means that the
patients taking part are divided into two (or more) groups at
random, usually by computer. One group will have the new treatment
and the other the standard treatment or a placebo, depending on the
individual trial. The computer ensures that the groups are similar
in terms of an individual's characteristics (for example age and
gender) to try to avoid any bias in the results.
In some phase III trials patients aren't told which treatment
they are getting; this is called a blind trial. In a double-blind
trial treatments are allocated by computer using codes, so even the
doctors don't know which patients are getting which treatment,
again to avoid biasing the results. This information is kept secret
until the end of the trial, although it can be accessed if
needed.
A new treatment usually has to show positive results in several
phase III trials before it is licensed to be prescribed more
widely. Eventually it may become part of standard treatment.
Phase IV trials
After a drug is licensed phase IV trials are carried out to find
out as much as possible about its safety and side effects, how well
it works in wider use and what the long-term risks and benefits are
for patients.
Quality of life studies
Well-designed treatment trials usually include a quality of life
study so that doctors can find out the impact of treatments and
their side effects on the everyday lives of patients, and sometimes
their families or carers too. These are usually done through
questionnaires and interviews.
Taking part in a clinical trial
There are a number of ongoing trials for pancreatic cancer
patients. Pancreatic Cancer UK aims to maintain an up-to-date
trials list: you can read some basic information about them
here.
Your doctor may have already asked if you are interested
in joining a clinical trial. But it is always a good idea to ask if
there are any trials that might be suitable for you so that you
know all the treatment options that may be available.
Each trial has strict criteria about who can be involved
so it may not be possible for you to take part in a particular
trial. This might be disappointing but you will still be offered
the best treatment and care available. The individual trial
summaries on our website contain some of the main criteria for
participation but there are often many other minor criteria which
we have not included. Your cancer specialist will be able to
explain the requirements for joining each trial.
If there is a clinical trial you are eligible to take part
in, before deciding whether or not to take part you will need to
talk it through with your specialist so that you know exactly what
is involved. You will probably have lots of questions - have a look
at the CancerHelp
UK website for a list of things you might want to ask. Once
you have all the information you need you can take time to make up
your mind. If you do decide to take part you will have to sign a
form saying you understand what is involved and agree to take part
(this is called informed consent). You can withdraw from the trial
at any time if you change your mind.
Open clinical trials for pancreatic
cancer in the UK
Details of current open trials for pancreatic cancer can
be found by following the links below:
Finding out more
You can read more detailed information about clinical
trials in general on the CancerHelp UK or Macmillan Cancer
Support websites.
or you can also look at: