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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Esophageal Cancer

Treatments: Radiation: radiation; Drug: paclitaxel; cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02461043

CH-GI-046

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: 386 estimated 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

Arm A

Experimental group

Description:

chemotherapy and radiotherapy

Treatment:

Radiation: radiation

Drug: paclitaxel; cisplatin

Arm B

Active Comparator group

Description:

radiotherapy

Treatment:

Radiation: radiation