A phase II trial of post-operative chemoradiotherapy for completely resected gastric cancer with D2 lymphadenectomy.

ABSTRACT

The optimal post-operative adjuvant treatment for completely resected gastric cancer with D2 lymphadenectomy remains controversial. The present study was a phase II trial on post-operative chemoradiotherapy in 30 patients with gastric cancer. Patients with stage II to IV (M0) gastric cancer received two cycles of chemotherapy prior to and following chemoradiotherapy. The chemotherapy consisted of a 2-h infusion of oxaliplatin (100 mg/m2) and folinic acid (100 mg/m2), which was followed by a 46-h continuous infusion of 5-fluorouracil (5-FU; 2,400 mg/m2) through a portable pump, repeated every 3 weeks. The chemoradiotherapy consisted of 45 Gy of radiotherapy for 5 weeks and 5-FU continuous infusion (350 mg/m2/day). In total, 30 patients were enrolled in this study. All patients underwent the chemoradiotherapy treatment as planned. A total of 10 (33.3%) patients relapsed; two (6.7%) locoregional relapses and mediastinum metastases, four (13.3%) peritoneal relapses, and four (13.3%) distant metastases. The three-year overall survival and disease-free survival rates were 72.7 and 65%, respectively. The toxicities of chemotherapy and radiotherapy, consisting of neutropenia, nausea and hand-foot syndrome, were observed. In conclusion, post-operative chemoradiotherapy following complete resection of gastric cancer with D2 lymphadenectomy is feasible in a significant subset of patients.