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

Smyth.

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