Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients

Esophagus Cancer Clinical Trial

Official title: Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin as First-line Treatment for Metastatic Esophageal Squamous Patients: a Prospective Multicenter, Randomized Controlled Clinical Study

Status Recruiting

Clinical Trial Summary

This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma patients.

Clinical Trial Description

Esophageal cancer is the 6th most common cause of cancer deaths worldwide and it is an endemic in many parts of the world, particularly in the developing countries, including China. Histologically, esophageal cancer can be classified as adenocarcinoma and esophageal squamous cell. carcinoma (ESCC) which is the most common histology in Asia. For locally advanced or metastatic ESCC patients, chemotherapy can improve overall survival (OS) and progression free survival (PFS). There is no standard first-line chemotherapy for ESCC patients. Cisplatin (DDP) plus fluorouracil is the most common used combination with a response rate of 25-35%. Previous studies showed that the combination of paclitaxel with cisplatin had good tolerance and efficacy to esophageal carcinoma. This is a prospective randomized control phase III clinical trial to compare the efficacy and safety between docetaxel/cisplatin and 5-Fu/cisplatin as the 1st line treatment in advanced or metastatic esophageal carcinoma patients.

Sample size:

This is a non-inferior study. The planned sample size was 358 patients, allowing for a 10% dropout rate and assuming the median progression free survival was 5.5 months in the experimental group and 4 months in the control group with a hazard ratio of 0.727, α=0.05, β=0.2. The planned enrolled time was 36 months and 12 months of follow up. The ratio between control and experimental group is 1:1. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Effects
• Esophageal Neoplasms
• Esophagus Cancer

• NCT number: NCT03002064
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Rui-Hua Xu, MD, PhD
• Phone: 86-020-87343333
• Email: xurh@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2016
• Completion date: December 2020