Metastatic Colorectal Cancer | DaVINCI (AG0103CR)
Randomised phase III trial of De Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer.
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Summary
Single agent Irinotecan and Irinotecan/5FU/LV combinations are frequently used second line regimens for patients with metastatic colorectal cancer, but it is unknown which is superior.
This study originally planned to recruit 300 patients with the primary end-point being tumour response. However, due to slower than expected recruitment, an amendment was proposed in September 2006 to revise the sample size and study end-points
Diarrhoea is the principal toxicity associated with both the single agent and combination regimens; it would therefore be useful to directly compare both and demonstrate a clinically significant difference in the rates of diarrhoea; the principal treatment limiting toxicity.
A revised sample size of 150 patients will allow the comparison of rates diarrhoea and side effects of treatment and effect on patients quality of life. This study will look at patients’ response to treatment and their overall survival.
