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Recruiting NCT04174079

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

Trial Parameters

Condition Thoracic Esophageal Squamous Cell Carcinoma
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 232
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2019-12-11
Completion 2029-05
Interventions
chemotherapy

Brief Summary

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Eligibility Criteria

Inclusion Criteria: 1. 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. 2. T≥3 or N≥1, and more than 15 lymph nodes were dissected. 3. Age ≥18 years and ≤75 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL. 6. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN. 7. Adequate renal function: serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min. 8. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent Exclusion Criteria

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