A phase II trial of neoadjuvant chemotherapy with docetaxel/cisplatin/capecitabine in thoracic esophageal squamous cell carcinoma.

TPS216 Background: The Optimal care for resectable squamous cell carcinoma of thoracic esophagus is uncertain. Effecacy of cisplatin-based two agent chemotherapy as neoadjuvant treatment remains limited. The combination of docetaxel, cisplatin, and capecitabine (DCX) for squamous cell carcinoma of thoracic esophagus in neoadjuvant set has not been investigated. Here, we conducted a phase II study to assess the efficacy and safety of neoadjuvant chemotherapy with modified DCX followed by surgery in patients with resctable thoracic Esophageal Squamous Cell Carcinoma. Methods: This is a single-arm prospective phase II study in Chinese patients. The main inclusion criteria are as follows: 1) Histologically proven squamous cell carcinoma of thoracic esophagus, T2-3, N0-2, T4aN0, M0 (UICC 7th edition); 2) age: 18-75 years, ECOG PS 0-1; 3) Enteral or parenteral feeding planned before the start of treatment if oral calorie intake < 1200 kcal; 4) written informed consent. Neoadjuvant modified DCX regimen consists of docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by Ivor Lewis Esophagectomy. Primary endpoint is 2-year overall survival rate. Key secondary endpoints include pathological response, R0/1 resection rate, disease free survival , safety and QOL by EORTC QLQ-C30. This study is recruiting in The Sixth Affiliated Hospital of Sun Yat-sen University and registered as NCT02915965. Clinical trial information: NCT02915965.