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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: paclitaxel; cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02133612

CH-GI-026

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

single arm paclitaxel and cisplatin

Experimental group

Treatment:

Drug: paclitaxel; cisplatin