Clinical trials

Clinical trials are the process by which new treatments are tested, evaluated, and the evidence gathered so that the decisions can be made about changing standard practice.

Cancer clinical trials are defined in three Phases.

Phase 1 trials are often 'first-in-man' - treatments which have never been tried on human patients before. Drug trials will be looking for safety information, side effects, and considering dosage issues. Numbers recruited will be small, sometimes no more than 10-15 patients.

Phase 2 trials examine which disease respond to the new treatment, and will be comparing dosages, assessing side effects and looking at outcomes. The numbers of patients recruited may be quite small (50 or so) but the data gathered will be the basis for later large scale trials. Occasionally Phase 2 trials are randomised so that alternative doses or methods of giving the new therapy can be compared.

Phase 3 trials are most often 'randomised controlled trials' (or RCTs). Here a standard therapy is compared with one or more new ones. Patients are randomly selected to receive one of the treatments, usually selected by computer to ensure there can be no bias. These trials are mostly large scale and can have thousands of patients in them, although with a rare cancer like sarcoma the numbers are more likely to be in the hundreds.

The UK Clinical Research Collaboration has produced a booklet on "Understanding Clinical Trials", which explains what clinical trials are and how and why they are carried out. It is designed to answer the many questions people may have when deciding whether to take part in a trial. Download.

Phase 1 and 2 trials are most likely to be at individual hospitals, or a very small number of hospitals. Phase 3 trials in sarcoma are often developed as pan-European trials through the EORTC (European Organisation for Research and Treatment of Cancer) and may be available in many UK treatment centres.

To find which trials are currently open in sarcoma follow the links below. No log-in is required in any of these databases. You may need to use the search facilities offered. Where necessary use the search term 'sarcoma' to keep the widest options available.

Cancer Help UK - a 'plain English' database of clinical trials in the UK maintained by Cancer Research UK

UK based Phase 3 trials (includes European trials open in the UK)

European (EORTC) Phase 3 trials (includes those open in the UK)

Page reviewed December 2009