Phase II Study of Capecitabine Combined With Intensity-Modulated Radiotherapy After D1/D2 Lymph Node Dissection in Patients with Gastric Cancer

Abstract Background: Adjuvant chemoradiotherapy (ACRT) with oral capecitabine and intensity-modulated radiotherapy (IMRT) was well tolerated in a phase I study in patients who had undergone partial or total gastrectomy for locally advanced gastric cancer. This phase II study aimed to further determine the efficacy and toxicity of this combination after radical resection and D1/D2 lymph node dissection (LND) for local advanced gastric patients.Methods: Forty patients (median age, 53 years; range, 24–71 years) with pathologically confirmed adenocarcinoma who underwent D1/D2 LND were included in this study. The patients received ACRT comprising IMRT (total irradiation dose: 45 Gy delivered in daily 1.8-Gy fractions on 5 days a week over 5 weeks) and capecitabine chemotherapy (dose: 800 mg/m² twice daily throughout the duration of RT). The primary study endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance.Results: The 3-year DFS and OS were 66.2% and 75%, respectively. The median time to recurrence was 19.5 months (range, 6.1–68 months). Peritoneal implantation (n = 10) was the most common recurrence pattern, and the lung was the most common site of extra-abdominal metastases (n = 5). Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while 11 underwent ACRT without receiving the entire course of capecitabine. There were no treatment-related deaths.Conclusion: The ACRT protocol described herein showed acceptable safety and efficacy for local advanced gastric cancer received radical gastrectomy and D1/2 LND.Trial registration: ClinicalTrials.gov, NCT01674959. Registered August 2012 - Retrospectively registered, http://www.isrctn.com/ISRCTN12345678