Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

• Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.

• No standard postoperative adjuvant chemotherapy has ever been established.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• ability to give informed consent

• histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins

• node-positive and pathologic stage M0

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Patients were enrolled 4 to 10 weeks after surgery

• Adequate organ function was required in 2 weeks of registration and was defined as:

serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits

Exclusion Criteria:

• prior chemotherapy or concurrent radiation therapy before esophagectomy

• R1 or R2 resection

• clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination