Spots Global Cancer Trial Database for Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer
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Trial Identification
Brief Title: Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer
Official Title: A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients
Study ID: NCT02972372
Conditions
Study Description
Brief Summary: The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.
Detailed Description: Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited. Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT). Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients. Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anyang Tumor Hospital, Anyang, Henan, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, China
Contact Details
Name: Shegan Gao, MD, PhD
Affiliation: The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Fuyou Zhou, MD, PhD
Affiliation: Anyang Tumor Hospital
Role: STUDY_CHAIR
Name: Ruinuo Jia, MD
Affiliation: The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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