NESC multicenter phase II trial in the preoperative treatment of gastric adenocarcinoma with chemotherapy (docetaxel-cisplatin-5FU + lenograstim) followed by chemoradiation (RTCT) based 5FU and oxaliplatin and surgery.

Abstract

95 Background: Perioperative chemotherapy is a standard treatment. The combination of Docetaxel- cddp-5FU(DCF) is a treatment in metastatic gastric cancer with high response rate. Preoperative RTCT is expected to increase the rate of curative resections and complete histological response. We investigate the efficacy of an optimal chemotherapy with DCF + lenograstim then preoperative RTCT with oxaliplatin - 5FU in gastric adk. Methods: Between 2009 and 2014, 33 patients with gastric adenocarcinoma(adk) were included. Inclusion criteria adk of stomach, cardia, Siewert II, III, according to staging classification T2bT3T4anyNM0 optional laparoscopy. Treatment consisted of 2 cycles docetaxel 75 mg/m2 I.V. day 1, cddp 75 mg/ m2 I.V. day 1, 5-FU 750 mg/m2 continuous infusion for 120 h, every 3 weeks and lenograstim followed by RTCT delivered in 25 daily fractions of 1.8 Gy in 5 weeks with 5Fu 250mg/m2 continuous infusion per day on days 1 to 35 and oxaliplatin 85mg/m2 day 1-14-28. Surgery was performed 4-6 weeks after RTCT. The primary endpoints were pathological response rate and secondary PFS, overall survival, morbidity and post operative mortality, toxicity. Results: 33 patients were included, 1patient progressive disease(PD) after 2 cycles of DCF, 32 patients received RTCT and 2 patients PD after RTCT, 1 patient refused surgery. 29 patients were operated and 3 non resected (peritoneal metastasis). 26 patients underwent surgery after RTCT (total gastrectomy n = 12, total gastrectomy and diaphragm surgery n = 1 lewis santy n = 11, subtotal gastrectomy n = 1, Enlarged gastrectomy transverse colectomy and partial pancreatic n = 1 D1 (n = 5) and D2 (n = 21) R0 resection rate was n = 26/26. Postoperative morbidity (n = 12) and mortality (n = 2), histology mean nods examined and involved respectively 16 and 2,5. pT0pN0 23% pT1pN0 19% pTpN2N3 20% others 38%. < 10% residual tumor 27% histologic complete response 23%. Conclusions: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a Phase III and compared with perioperative CT. Clinical trial information: NCT01565109.