Rougier.
Methods | Multicentre randomised controlled trial. Generation of allocation schedule truly random. |
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Participants | 166 patients with unresectable hepatic metastases from primary colorectal cancer. Primary tumour had been resected. Hepatic metastases unresectable. No evidence of extrahepatic disease or ascites. WHO perfomance status 0‐2. Less than 75% hepatic involvement with tumour. Specified bilirubin level for inclusion. | |
Interventions | Hepatic artery infusion of Floxuridine (0.3mg/kg/day) for 14 days every 4 weeks vs Observation or systemic bolus 5‐FU infusion (500mg/m2/day) for 5 days every 4 weeks | |
Outcomes | Survival, Progression, Tumour response, Complications, Toxicity | |
Notes | 24/82 in treatment group and 41/82 in control group had systemic chemotherapy Analysis by intention to treat | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |