This section contains information about clinical trials in general and specifically clinical trials for pancreatic cancer currently running in the UK that you may be able to take part in.
Introduction to the clinical trials information
This page provides background information to help explain the individual trial summaries that follow. Each trial summary gives:
- 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
- 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 all aspects of the disease. This may include evaluation of new treatments, better ways of giving existing treatment or controlling treatment side effects. They can also look at cancer risk and prevention, screening and diagnosis. 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 reviewed and approved by independent scientists and by an independent 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 of 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 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 (metastatic) 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), and discover more about the best dose to use, and the side effects and how to manage them. At this stage 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 placebo. A placebo is an inactive form of treatment made to look like the real treatment being used in the trial (a dummy drug). It is used in research trials if there is no standard treatment to compare the new treatment with, or if the treatment being trialled is being added to the standard treatment. The trial participants do not know whether they are receiving the active treatment or not, and the aim is to prevent bias in the research.
If the results of the phase II trial are positive the treatment may move into phase III trial testing.
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 a computer divides the trial participants into two (or more) groups at random. One group will have the new treatment and the other the standard treatment and possibly a placebo (see above), depending on the exact nature of the trial. The computer ensures that the groups are similar in terms of individuals' 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 confidential 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 gets used more widely or accepted as 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 often 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. The individual trial summaries on this website give 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 exact requirements for joining each trial. You might be disappointed if you don't meet the criteria for taking part in a particular trial, but you will still be offered the best treatment and care available.
If there is a clinical trial you are eligible to join, 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 giving 'informed consent'. You can withdraw from the trial at any time if you change your mind.
Even if you seem to be eligible to join a trial and you have given your consent, screening tests for the study may show up something that means you don't meet the criteria after all. This can be very disappointing and frustrating, but you will still be given the best treatment and care available outside the trial.
The current open trials for pancreatic cancer page contains information on the following trial types:
- Trials for operable pancreatic cancer (when surgical resection is possible)
- Trials for inoperable pancreatic cancer (when surgery is not possible/ advanced cancer or recurrent cancer following surgery)
- Diagnosis Trials
- Trials for multiple tumour types
- Trials investigating the causes of cancer
Finding out more
or you can also look at:
- CancerHelp UK clinical trials database
- UK Clinical Research Network Portfolio Database
Published December 2013
Review date December 2015