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

Recruiting now · Not applicable

Conditions studied: Thoracic Esophageal Squamous Cell Carcinoma

In brief

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

Key facts

Study ID

NCT04174079

Run by

Sun Yat-Sen University Cancer Center

People needed

232

Starts

2019-12-11

Expected to finish

2029-05-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sun Yat-sen Uniersity Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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