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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sun Yat-sen Uniersity Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Peng Lin, professor
linpeng@sysucc.org.cn
+86-20-87343314
Backup
Xing Ru Ping
xingrp@sysucc.org.cn
+86-20-87343736
Time Frame
Start Date: 2019-12-11
Estimated Completion Date: 2029-05
Participants
Target number of participants: 232
Treatments
Experimental: 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
No_intervention: control group
patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov