Randomized clinical trial of extensive intraoperative peritoneal lavage versus standard treatment for resectable advanced gastric cancer (CCOG 1102 trial). Issue 12 (1st October 2019)

• Record Type: Journal Article
• Authors: Misawa, K; Mochizuki, Y; Sakai, M; Teramoto, H; Morimoto, D; Nakayama, H; Tanaka, N; Matsui, T; Ito, Y; Ito, S; Tanaka, K; Uemura, K; Morita, S; Kodera, Y
• Is Part Of: British journal of surgery. Volume 106:Issue 12(2019)
• Page Start: 1602
• Page End: 1610
• Publication Date: 2019-10-01
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1002/bjs.11303
• Languages: English
• ISSNs: 0007-1323

Abstract

Abstract: Background: A survival benefit of extensive intraoperative peritoneal lavage (EIPL) has been reported in patients with gastric cancer with positive peritoneal cytology. The hypothesis of this study was that EIPL may reduce peritoneal recurrence in patients with advanced gastric cancer who undergo surgery with curative intent. Methods: This was an open-label, multi-institutional, randomized, phase 3 trial to assess the effects of EIPL versus standard treatment after curative gastrectomy for resectable gastric cancer of T3 status or above. The primary endpoint was disease-free survival (DFS); secondary endpoints were overall survival, peritoneal recurrence-free survival and incidence of adverse events. Results: Between July 2011 and January 2014, 314 patients were enrolled from 15 institutions and 295 patients were analysed (145 and 150 in the EIPL and no-EIPL groups respectively). The 3-year DFS rate was 63·9 (95 per cent c.i. 55·5 to 71·2) per cent in the EIPL group and 59·7 (51·3 to 67·1) per cent in the control group (hazard ratio (HR) 0·81, 95 per cent c.i. 0·57 to 1·16; P = 0·249). The 3-year overall survival rate was 75·0 (67·1 to 81·3) per cent in the EIPL group and 73·7 (65·9 to 80·1) per cent in the control group (HR 0·91, 0·60 to 1·37; P = 0·634). Peritoneal recurrence-free survival was not significantly different between the two groups (HR 0·92, 0·62 to 1·36; P = 0·676). No intraoperative complications related to EIPL were observed. Conclusion: EIPL did not improve survival or peritoneal recurrence in patients who underwent gastrectomy for advanced gastric cancer. Registration number: 000005907 (http://www.umin.ac.jp/ctr/index.htm ). Graphical Abstract: This trial was conducted to clarify the effects of extensive intraoperative peritoneal lavage (EIPL) therapy after curative gastrectomy for resectable cT3 gastric cancer. The 3-year DFS rate was slightly better in the EIPL group (63·9 per cent) than in the no-EIPL group (59·7 per cent), but the difference was not statistically significant (hazard ratio 0·81, 95 per cent c.i. 0·57 to 1·16; P = 0·249). Superiority of EIPL therapy was not demonstrated. No benefit