Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer

Summary

A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

Conditions

• Stage III Esophageal Squamous Cell Carcinoma
• Stage II Esophageal Squamous Cell Carcinoma

Interventions

OTHER

2 cycles cisplatin-5-fluorouracil

2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.

OTHER

4 cycles cisplatin-5-fluorouracil

4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.

RADIATION

Radiotherapy

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology

  lead OTHER

Principal Investigators

• Shegan Gao, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

• Tanyou Shan, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaoshan Feng, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

• Jiachun Sun, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

• Xinshuai Wang, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

• Guoqiang Kong, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaozhi Yuan, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Ruinuo Jia, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Zhou, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Jing Ren, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Ruina Yang, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Wei Wang, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Yongxuan Liu, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Wang, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Shiyuan Song, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Weijiao Yin, Master · The First Affiliated Hospital of Henan University of Science and Technology

• Yali Zhang, Master · The First Affiliated Hospital of Henan University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2017-12-31

Completion

2020-12-31

Countries

• China

Study Locations