Cunningham.

Methods	Multicentre randomised controlled trial. Generation of allocation schedule by computer generation (truly random). Ratio of irinotecan to supportive care 2:1.
Participants	279 patients with metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil. Age 18‐75 years, WHO performance status 0‐2, had 1 adjuvant and no more than 2 palliative fluorouracil‐based regimes. Excluded if had previous treatment with topoisomerase I inhibitors, bulky disease, metastases in central nervous system, or unresolved bowel obstruction or diarrhoea. Specified levels of neutrophils, platelets, bilirubin, liver transaminases and creatinine required for inclusion
Interventions	Irinotecan 350mg/m2 over 90min intravenous infusion every 3 weeks + supportive care vs Supportive care alone : antibiotics, analgesics, transfusions, corticosteroids, psychotherapy, and other symptomatic therapy except irinotecan / other topoisomerase I inhibitors. Localised radiation therapy was allowed provided that the dose delivered was in the palliative range according to institutional standards
Outcomes	Overall survival, Disease progression, Performance status, Body weight, Tumour‐related symptoms, Quality of life.
Notes	In the supportive care group 28 (31%) received chemotherapy, mainly with fluorouracil regimens. Analysis was by intention to treat.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate