Contest. ESPAC-1 included pts with grossly resected adenocarcinoma of the pancreas. The study used a 2 × 2 factorial design; Sg +/− CRT and +/− adj chemo. Adj CRT was similar to GITSG. Adj chemo was 6 mos of 5-FU. MS was 15 mos (CRT) vs. 16 mos (no CRT), NSS; OS was 20 mos (chemo) vs. 14 mos (no chemo) (p = 0.0005).

Criticisms: Physicians could randomize pts into 2 × 2 or directly into 1 of the 2 randomizations. “Background Tx” was allowed (i.e., observed pts may have rcvd chemo +/− RT). There was no central RT QA. (NeoptolemosJP et al., Lancet 2001) Note: Analysis of 2 × 2 subset suggests that CRT had a deleterious effect; 5-yr OS was 10% (CRT) vs. 20% (no CRT) (p = 0.05).