Spots Global Cancer Trial Database for Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
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Trial Identification
Brief Title: Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
Official Title: Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer
Study ID: NCT02607540
Study Description
Brief 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.
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 two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.
Eligibility
Minimum Age: 45 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, Doctor
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Tanyou Shan, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Xiaoshan Feng, Doctor
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Jiachun Sun, Doctor
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xinshuai Wang, Doctor
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Guoqiang Kong, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhi Yuan, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Ruinuo Jia, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Zhou, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jing Ren, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Ruina Yang, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Wei Wang, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yongxuan Liu, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Wang, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Shiyuan Song, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Weijiao Yin, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yali Zhang, Master
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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