About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
chemotherapy
Drugpatients 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
Treatment groups
Trial outcomes
Primary outcomes
Disease-free survival
Patients were images with computed tomography (CT) scan
Secondary outcomes
overall survival
Patients were images with computed tomography (CT) scan
Sponsors and contacts
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Sun Yat-Sen University Cancer Center
Lead sponsor
Sun Yat-sen University
Sponsor institution