Postoperative adjuvant chemotherapy for grossly serosa-positive advanced gastric cancer: A randomized phase III trial of intraperitoneal cisplatin and early mitomycin-C plus long-term doxifluridine plus cisplatin (iceMFP) versus mitomycin-C plus short- term doxifluridine (Mf) (AMC 0101) (NCT00296322)

LBA4511 Background: To improve the postoperative adjuvant chemotherapy in serosa-involving AGC, we have adopted the strategies of intraperitoneal and early start of chemotherapy, as well as prolongation of oral fluoropyrimidine and addition of cisplatin (P) to Mf regimen. This phase III trial was designed to determine whether experimental iceMFP could improve 3 year relapse free survival rate (3yRFSR) compared to control Mf. (For HR 0.66, α=0.05, β=0.2, N=527 with 192 events) Methods: Pts whose tumor were grossly seroa-positive and able to be resected curatively were randomized during operation to receive either Mf or iceMFP. Pts with postoperative pathologic stage I or IV (M1) were excluded after surgery. For Mf, 20 mg/m2 of mitomycin-C (M) was injected 3–6 wks after surgery and 4 wks later, 460–600 mg/m2/day of doxifluridine was administered orally for 3 months. For iceMFP, 100 mg of P in 1 L of saline was administered intraperitoneally for 2 h during surgery and 15 mg/m2 of M was injected 1 day after s...