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

Phase 3

• Conditions: Esophageal Cancer
• Interventions: Radiation: radiation; Drug: paclitaxel; cisplatin

• Registration Number: NCT02461043
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-30
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-29
• Last Update Posted: 2015-09-01
• Primary Completion: 2020-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 386

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	radiation	radiotherapy
Arm A	radiation	chemotherapy and radiotherapy
Arm A	paclitaxel; cisplatin	chemotherapy and radiotherapy

Primary Outcome Measures

Name	Time	Method
3 year relapse free survival	5 years

Secondary Outcome Measures

Name	Time	Method
3 year overall survival	5 years

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China