Local advanced gastric carcinoma (LAGC) including stage IB, II and III disease is suggested to be potentially cured by R0 resection. Adjuvant chemotherapy such as oxaliplatin plus capecitabine or S1 can increase the overall survival of patients with early stage LAGC but not prolong the survival of patients with more progressive, later stage such as stage III gastric cancer. It's needed to evaluate whether preoperative chemotherapy combined with D2 gastrectomy plus adjuvant chemotherapy can provide longer survival to those patients with later stage LAGC. In this study, we plan to evaluate the efficacy and safety of neoadjuvant chemotherapy with oxaliplatin plus capecitabine in more progressive LAGC.
This is a single arm, open-label, multicenter, phase II trial. Patients with newly diagnosed, histologically documented gastric adenocarcinoma, clinically diagnosed stage T2-3/N + M0 or T4aN + M0 according to CT/MRI scan, and judged to be resectable at laparoscopy will be enrolled. Patients will be treated by capecitabine (1000 mg/m2, bid, day 1 ∼ 14 every 3 weeks) plus oxaliplatin (130 mg/m2, d1, every 3 weeks) 8 cycles perioperatively in total. After receiving 4 cycles of preoperative XELOX, patients without progressive disease will be given surgical evaluation and those who are supposed to be curable will be given radical D2 gastrectomy; then the patients will receive another 4 cycles of postoperative chemotherapy within 8 weeks after resection. The primary endpoint is the response rate (ORR) of neoadjuvant chemotherapy. Secondary end-points include D2 gastrectomy rate, pathological response, 3-year progression free survival (PFS) rate, 5-year overall survival (OS) rate, health-related quality of life (HRQoL) and safety profiles. Assuming median ORR increasing from 40% to 55%, results from a single-sided log rank test with a power of 80% for further evaluation, the sample size would be 47. Based on these assumptions and 10% dropout rate, a total of 55 patients are needed to be observed. Recruitment began in Sep 2013 and the final data analysis will be at Oct 2018.
Clinical trial identification
All authors have declared no conflicts of interest.