Allen Mersh.
Methods | Single centre randomised controlled trial. Generation of allocation schedule by minimisation. |
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Participants | 100 patients with synchronous or metachronous colorectal liver metastases, excluding those with extensive metastases (>60% liver replacement), less than 4 discrete resectable metastases, ascites, raised bilibubin, evidence of disease outside the liver or a history of systemic chemotherapy. Age < 75 years | |
Interventions | Hepatic artery infusion Floxuridine (0.2 mg/kg body weight). 14‐day continuous infusion followed by 14‐day rest, and cycle repeated. Treatment continued until progression or toxicity. vs Conventional palliation : resection of primary tumour if diagnosed synchronously. Analgesia, corticosteroids, and systemic chemotherapy permitted. Hepatic artery infusion was not allowed. | |
Outcomes | Overall survival, Quality of life, Toxicity | |
Notes | Paper suggests that most of the control group (39/49) did not receive systemic chemotherapy in addition to conventional palliation. Analysis was by intention to treat | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |