ICG clearance in patients randomised to FOLFOX or FOLFIRI
Research type
Research Study
Full title
Indocyanine Green Clearance in patients undergoing chemotherapy for colorectal liver metastases: randomisation to FOLFOX or FOLFIRI
IRAS ID
124145
Contact name
Marcos Kostalas
Contact email
Eudract number
2013-0021-3123
Research summary
This study compares the amount of liver damage caused by the 2 main combinations of chemotherapy used in patients with cancer of the bowel that has spread to the liver. If these patients’ liver tumours can be safely and completely resected, they often undergo chemotherapy to shrink the tumours before having liver surgery. If however the cancer is too widespread to carry out curative surgery, they will have chemotherapy to slow the progress of the cancer. The combinations of chemotherapy used in these 2 patient groups is the same and they all cause damage to the liver. As liver surgeons, we want to minimise the amount of damage caused to normal liver tissue because once a portion is take away at surgery, the remaining liver has to compensate. This is important if the patients are to make a full recovery.
We therefore want to randomise patients to one of the two combinations of chemotherapy in order to compare the level of liver damage they cause. We'll do is using an established and sensitive measure of liver function called 'Indocyanine Green (ICG) Clearance' which measures how quickly the liver manages to excrete an injected dye (ICG) from the blood. This gives us a direct measure of overall liver function. By determining which combination is most harmful and after how many cycles the damage becomes substantial, we can try and adjust the way we give these patients chemotherapy to reduce the harm and improve patient outcomes.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
13/LO/0422
Date of REC Opinion
2 Dec 2013
REC opinion
Further Information Favourable Opinion