Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
Sun Yat-sen University
232 participants
Dec 11, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria6
- 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.
Interventions
patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04174079