Hafstrom.
Methods | Multicentre randomised controlled trial. Generation of allocation schedule truly random. Concealment of allocation adequate (personal communication with investigator) |
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Participants | 60 patients with non‐resectable liver metastases and no extrahepatic cancer. Age<= 75 years. | |
Interventions | Temporary hepatic artery occlusion with intraportal infusion of 5‐Fluorouracil (1000mg/m2/day) for 5 days plus allopurinol 300mg p.o. for 10 days. Repeated every 6 weeks until progression. After 2 years, interval between treatments was prolonged. vs Control : no regional or systemic treatment | |
Outcomes | Overall survival, Tumour response, Complications | |
Notes | 57 of 60 randomised patients were treated at one centre. 6 patients were excluded after randomisation because of major protocol violations (not intention to treat) 5/32 in treatment group and 3/28 in control group had subsequent systemic chemotherapy | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |