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 |
|