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. 2000 Jan 24;2000(1):CD001545. doi: 10.1002/14651858.CD001545

Rougier.

Methods Multicentre randomised controlled trial.
Generation of allocation schedule truly random.
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