A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    May 17, 2029
  • participants needed
    232
  • sponsor
    Sun Yat-sen University
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Updated on 17 October 2022
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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

Description

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.

Details
Condition Thoracic Esophageal Squamous Cell Carcinoma
Treatment Chemotherapy
Clinical Study IdentifierNCT04174079
SponsorSun Yat-sen University
Last Modified on17 October 2022

Eligibility

 Yes No Not Sure

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) ≥
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
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