Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma

Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

• Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
• No standard postoperative adjuvant chemotherapy has ever been established.

Inclusion Criteria:

• ability to give informed consent
• histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
• node-positive and pathologic stage M0
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients were enrolled 4 to 10 weeks after surgery
• Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits

Exclusion Criteria:

• prior chemotherapy or concurrent radiation therapy before esophagectomy
• R1 or R2 resection
• clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination