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. 2012 Mar 14;2012(3):CD004078. doi: 10.1002/14651858.CD004078.pub2
Methods RCT (Randomised Controlled Trial); multicentre (Japan)
Participants Patients with Dukes A, B and C (TNM stage I, II, III) rectal cancer undergoing radical surgery of the primary tumor (n=447)
Interventions 2‐arm trial: patients randomly assigned to: A) surgery alone (n=229), or B) surgery + adjuvant chemotherapy (n=218) with Uracil‐Tegafur (UFT, an oral fluoropyrimidine) plus intravenous 5‐FU and MMC
Outcomes Disease‐free survival (DFS) and overall survival (OS)
Notes The data are from an individual patient data (IPD) meta‐analysis (Sakamoto 2007 (JFMTC15‐1)) since no original article has been published on this RCT
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk
Selective reporting (reporting bias) High risk Data from an IPD meta‐analysis (no original article)
Other bias Low risk