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Randomised Phase II trial of de Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer (DaVINCI)

ABSTRACT: Interventions: Irinotecan versus irinotecan + 5-FU/leucovorin. Duration: Until patients progress Primary outcome(s): Rates of Grade 3/4 diarrhoea[Every 2 weeks (combination arm) and Every 3 weeks (single agent arm) using the CTC AE Version 3.0 scale.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Metastatic Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2452180 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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