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

NCT04174079 | Recruiting DMC

• 1 other identifier: B2019-061-01
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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

Conditions

Thoracic Esophageal Squamous Cell Carcinoma

Keywords

adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Patients were images with computed tomography (CT) scan

  At most 5 years after enrollment

Secondary Outcomes (1)

• overall survival

  At most 5 years after enrollment

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: chemotherapy

control group

NO INTERVENTION

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.

Interventions

chemotherapy DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Uniersity Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Peng Lin, professor

CONTACT

+86-20-87343314; linpeng@sysucc.org.cn

Xing Ru Ping

CONTACT

+86-20-87343736; xingrp@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start: December 11, 2019
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (1)