The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy

Summary

A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. But in China because of its severer toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to its characristic of low toxic reaction.

The purpose of this study is to confirm the efficacy and safety of the different cycles(two cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma radical concurrent chemoradiotherapy. A total of 60 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
• Esophageal Neoplasms

Interventions

DRUG

Capecitabine(Aibin)

capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total

DRUG

Oxaliplatin(Aiheng)

Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V.

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 Zhengzhou University

  collaborator OTHER

• Xinyang Central Hospital

  collaborator OTHER

• Anyang Tumor Hospital

  collaborator OTHER

• No. 150 Central Hospital of the Chinese People Liberation Army

  collaborator OTHER_GOV

• 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

• Dan 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

• Yali Zhang, 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

• Wei 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

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