Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.

Inclusion criteria

• Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
• T≥3 or N≥1, and more than 15 lymph nodes were dissected.
• Age ≥18 years and ≤75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Adequate hematological function:

absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.

• Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
• Adequate renal function:

serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.

• Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent

Exclusion criteria

• Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
• Serious postoperative complications that will affect progress of chemotherapy.
• Patients with chemotherapy contraindications.
• Women who are pregnant or breast-feeding or who are planning for pregnancy.
• Unable to complete the follow-up as planned.
• Without informed consent due to psychological, family, social and other factors.