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

Not Applicable

Recruiting

• Conditions: Thoracic Esophageal Squamous Cell Carcinoma
• Interventions: Drug: chemotherapy

• Registration Number: NCT04174079
• Lead Sponsor: Sun Yat-sen University

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2019-12-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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

1. 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.
2. Serious postoperative complications that will affect progress of chemotherapy.
3. Patients with chemotherapy contraindications.
4. Women who are pregnant or breast-feeding or who are planning for pregnancy.
5. Unable to complete the follow-up as planned.
6. Without informed consent due to psychological, family, social and other factors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Disease-free survival	At most 5 years after enrollment	Patients were images with computed tomography (CT) scan

Secondary Outcome Measures

Name	Time	Method
overall survival	At most 5 years after enrollment	Patients were images with computed tomography (CT) scan

Trial Locations

Locations (1)

Sun Yat-sen Uniersity Cancer Center; 🇨🇳 Guangzhou, Guangdong, China