FLICOR Trial
Research type
Research Study
Full title
A randomised feasibility study evaluating the effect of perioperative intravenous lIdocaine on colorectal cancer outcome after surgery
IRAS ID
1004491
Contact name
Raha West
Contact email
Sponsor organisation
Imperial College London
Eudract number
2021-006185-20
ISRCTN Number
ISRCTN29594895
Clinicaltrials.gov Identifier
Research summary
Summary of Research
Surgery is the main treatment for large bowel cancer. Unfortunately, in some patients, cancer can come back after surgery. This is quite a big problem.Even before surgery, a small number of cancer cells can move around the body. The body can deal with these cells, but if there are lots of them, they can clump together (known as micrometastases) and cause cancer to spread. When the body reacts to heal the surgical wound, sadly, this creates an environment that can encourage cancer cells to grow.
Lidocaine is a local anaesthetic drug. It is safe and widely used, such as at the dentists. Scientists have found in laboratory and animal studies that lidocaine may be able to prevent and kill micrometastases.
This feasibility (small) study aims to see if it is possible to run a big study looking at the effect of lidocaine on large bowel cancer recurrence after surgery.
The project will see:
• if there are any problems in giving lidocaine;
• if patients and clinicians would be happy to take part in a study using a design where some patients get the drug and others get a non-active substance (known as placebo);
• how many patients can we get from the different types and stages of bowel cancer;
• if patients can be followed up after 6-and-12 months successfully;
• if we can collect all the data that we would need;
• what measures might work well for the future study;
• if blood tests can explain how lidocaine might work in patients.The study will involve patients getting either lidocaine or placebo during large bowel cancer surgery, and:
• answering questionnaires to measure quality of life;
• having their records looked at to see if the cancer comes back;
• give feedback to see how they get on with the study processes;
• having extra blood testsSummary of Results
Screening and recruitment: 671 people were screened; 34 were eligible; 25 were approached; 15 agreed; 14 were randomised (6 lidocaine, 8 placebo). All completed follow-up as scheduled.
What were the main findings?
• Feasibility: four out of five pre-set targets were met (approach rate, consent rate, complete follow-up, clinician willingness).
The 24-hour infusion target was not met overall because one site lacked monitored beds after surgery; the second site delivered 100% of infusions.
• Safety: no lidocaine-related safety events were reported.
• Clinical outcomes (12 months): all participants were alive without evidence of cancer recurrence at 6 and 12 months; hospital days were similar between groups.
• Biology: blood tests suggested faster resolution of post-operative inflammation with lidocaine and a marked reduction in cancer marker by day 3 (−74.5% vs 0%; p=0.0025).
• Quality of life and costs: quality of life improved in both groups; scores were higher with lidocaine at 12 months in the subset followed. Total NHS costs were numerically lower with lidocaine over 12 months; estimates are imprecise and need confirmation in a larger trial.
What do the results mean?
Giving lidocaine in the NHS during bowel cancer surgery is feasible and appears safe when post-operative monitoring is available. The biological and quality-of-life signals are encouraging but a larger study is needed to find out if lidocaine reduces cancer coming back.
Where can the public find more information?
Trial registrations: ISRCTN29594895 and NCT05250791. A full manuscript reporting these results is being submitted for publication in peer review journal.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0114
Date of REC Opinion
23 Mar 2022
REC opinion
Further Information Favourable Opinion