CR09/FOCUS 2
Drug treatment for bowel cancer: making the best choices when a milder treatment is needed
What is the best treatment for older people with colorectal cancer?
What was this study about?
People with colorectal cancer usually have an operation to remove the cancer. Sometimes the cancer cannot be removed by surgery or comes back and spreads to other parts of the body. When this happens, doctors usually offer people chemotherapy (a type of anti-cancer treatment) using a drug called 5FU and sometimes add to this a drug called oxaliplatin. Another drug that can be used is capecitabine, this is similar to 5FU but is given as a tablet. There is information on the use of these drugs in young, fit patients; however there is very little information on their use in older, less fit patients.
The CR09 trial sometimes called FOCUS2 was aimed at older people and people who were less fit. The drugs were initially given at a lower dose with the aim of avoiding side effects.
The FOCUS2 trial aimed to do three things. First, to test which chemotherapy drugs worked best and in which combination. Patients received either 5FU, 5FU and oxaliplatin, capecitabine or capecitabine and oxaliplatin. Second, to see which chemotherapy gave the best quality of life for patients. Third, by collecting information at the start of the trial using a detailed health assessment aimed at older, less fit patients, the trial tried to identify which patients will benefit most from these drugs.
What difference did this study make?
This trial showed that it is possible to conduct trials in older, less fit patients. It showed that starting at a lower dose and then increasing the dose if the side effects of the drugs have not been too troublesome is possible. Finally, it showed that a detailed health assessment before starting chemotherapy may help predict who will benefit most from these drugs.
The trial also showed that it is possible to carry out trials in older, less fit patients and because of this there are more trials being designed to look at drugs in older, less fit patients.
Type of study
Randomised trial
Contact details
Who funded the study?
The UK charity Cancer Research UK.
When did it take place?
This trial began recruiting patients in 2004 and closed to recruitment in 2006. The results of the trial were published in 2011 in The Lancet.
Where did it take place?
UK
Who was included?
459 frail or older people with colorectal cancer which had spread to other parts of their body took part in this trial.