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

NCT ID: NCT04174079

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2029-05-31

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.

Conditions

Thoracic Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

chemotherapy

Intervention Type: 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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Peng Lin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen Uniersity Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Lin, professor

Role: CONTACT

linpeng@sysucc.org.cn

+86-20-87343314

Xing Ru Ping

Role: CONTACT

xingrp@sysucc.org.cn

+86-20-87343736

Facility Contacts

Peng Lin, professor

Role: primary

linpeng@sysucc.org.cn

+86-20-87343314

Xing Ru Ping

Role: backup

xingrp@sysucc.org.cn

+86-20-87343736

Other Identifiers

B2019-061-01

Identifier Type: -

Identifier Source: org_study_id