Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Summary

A three-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. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.

The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

Conditions

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

Interventions

DRUG

Capecitabine(Aibin)

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

DRUG

Oxaliplatin(Aiheng)

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

RADIATION

Radiotherapy

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

Sponsors & Collaborators

• Luoyang Central Hospital

  collaborator OTHER

• Military 150 Hospital

  collaborator UNKNOWN

• Anyang Cancer Hospital

  collaborator UNKNOWN

• Nanyang Central Hospital

  collaborator OTHER

• Henan Oncology Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Xinyang Medical College

  collaborator UNKNOWN

• Sanmenxia Central Hospital

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Shegan Gao, M.D Ph.D · The First Affiliated Hospital of Henan University of Science and Technology

• Tanyou Shan, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaoshan Feng, M.D Ph.D · The First Affiliated Hospital of Henan University of Science and Technology

• Jiachun Sun, M.D Ph.D · The First Affiliated Hospital of Henan University of Science and Technology

• Xinshuai Wang, M.D Ph.D · The First Affiliated Hospital of Henan University of Science and Technology

• Guoqiang Kong, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaozhi Yuan, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Ruinuo Jia, M.D Ph.D · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Zhou, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Jing Ren, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Ruina Yang, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Wang, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Wei Wang, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Yali Zhang, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Yongxuan Liu, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Weijiao Yin, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Shiyuan Song, M.D M.S · The First Affiliated Hospital of Henan University of Science and Technology

• Guobao Zheng, M.D Ph.D · No. 150 Central Hospital of the Chinese People Liberation Army

• Daoke Yang, M.D M.S · The First Affiliated Hospital of Zhengzhou University

• Jianhua Wang, M.D Ph.D · Henan Tumor Hospital

• Fuyou Zhou, M.D Ph.D · Anyang Tumour Hospital of Henan province

• Nengchao Wang, M.D M.S · Anyang Tumour Hospital of Henan province

• Anping Zheng, M.D M.S · Anyang Tumour Hospital of Henan province

• Zhanhui Miao, M.D M.S · Affiliated Hospital of Xinxiang Medical University, Henan province

• Ruiwen Zhang, M.D M.S · Xinxiang Central Hospital of Henan province

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2022-09-13

Completion

2025-04-01

Countries

• China

Study Locations