Gerard.
Methods | Multicentre randomised controlled trial. Generation of allocation schedule truly random (personal communication with investigator). Stratified according to measurability of lesion and presence / absence of symptoms |
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Participants | 74 patients with unresectable colorectal liver metastases. Primary colorectal adenocarcinoma had been resected during previous surgical operation. Age < 70 years, Karnofsky performance score >= 60. | |
Interventions | Hepatic artery ligation with portal infusion 5‐Fluorouracil 600mg/m2/day for at least 10 days (max. 20 days) . Treatment repeated every 6 weeks until progression or severe side effects vs Hepatic artery ligation alone | |
Outcomes | Survival, Progression, Tumour response, Complications, Toxicity | |
Notes | Paper does not report whether patients in the control group received subsequent systemic chemotherapy. Analysis not by intention to treat as 7 patients withdrawn from analysis after randomisation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |