Smyth.
Methods | Multicentre randomised controlled trial. Generation of allocation schedule truly random. |
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Participants | 190 patients with recurrent or metastatic colorectal cancer not amenable to curative surgery and/or radiotherapy. WHO performance status 0‐2, life expectancy at least 3 months. Specified levels of haematological and hepatic function required. Excluded if previous chemotherapy or radiotherapy to lesions. Patients with concomitant malignant disease were excluded. Excluded if active uncontrolled infection or poor medical risks because of non‐malignant systemic disease. | |
Interventions | Tauromustine (130mg/m2 p.o. every 5 weeks). Continued until evidence of disease progression
vs
No chemotherapy Radiotherapy was permitted for palliative treatment. Other cytotoxic agents were not permitted. |
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Outcomes | Survival, Progression, Tumour response, Quality of life, Performance status, Toxicity | |
Notes | Only published as a short communication. Additional information supplied by Kabi Pharmacia. Analysis was by intention to treat. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |