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

Thoracic Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174079
• Other study ID #: B2019-061-01
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: May 2029

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Peng Lin, professor
• Phone: +86-20-87343314
• Email: linpeng[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Thoracic Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Sun Yat-sen Uniersity Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Patients were images with computed tomography (CT) scan	At most 5 years after enrollment
Secondary	overall survival	Patients were images with computed tomography (CT) scan	At most 5 years after enrollment