Spots Global Cancer Trial Database for Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
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Trial Identification
Brief Title: Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
Official Title: Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer
Study ID: NCT02025036
Study Description
Brief 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.
Detailed Description: We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Contact Details
Name: Shegan Gao, M.D Ph.D
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Tanyou Shan, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Xiaoshan Feng, M.D Ph.D
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Jiachun Sun, M.D Ph.D
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xinshuai Wang, M.D Ph.D
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Guoqiang Kong, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhi Yuan, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Ruinuo Jia, M.D Ph.D
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Zhou, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jing Ren, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Ruina Yang, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Wang, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Wei Wang, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yali Zhang, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yongxuan Liu, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Weijiao Yin, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Shiyuan Song, M.D M.S
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Guobao Zheng, M.D Ph.D
Affiliation: No. 150 Central Hospital of the Chinese People Liberation Army
Role: PRINCIPAL_INVESTIGATOR
Name: Daoke Yang, M.D M.S
Affiliation: The First Affiliated Hospital of Zhengzhou University
Role: PRINCIPAL_INVESTIGATOR
Name: Jianhua Wang, M.D Ph.D
Affiliation: Henan Tumor Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Fuyou Zhou, M.D Ph.D
Affiliation: Anyang Tumour Hospital of Henan province
Role: PRINCIPAL_INVESTIGATOR
Name: Nengchao Wang, M.D M.S
Affiliation: Anyang Tumour Hospital of Henan province
Role: PRINCIPAL_INVESTIGATOR
Name: Anping Zheng, M.D M.S
Affiliation: Anyang Tumour Hospital of Henan province
Role: PRINCIPAL_INVESTIGATOR
Name: Zhanhui Miao, M.D M.S
Affiliation: Affiliated Hospital of Xinxiang Medical University, Henan province
Role: PRINCIPAL_INVESTIGATOR
Name: Ruiwen Zhang, M.D M.S
Affiliation: Xinxiang Central Hospital of Henan province
Role: PRINCIPAL_INVESTIGATOR
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