Spots Global Cancer Trial Database for Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
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Trial Identification
Brief Title: Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Official Title: Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Study ID: NCT02644408
Study Description
Brief Summary: Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance put, chemotherapy, improve the quality of life, is widely used in tumor radiation and chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal bleeding, arrhythmia and other serious complications, there is no unified standard. The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical chemoradiation curative effect and side effects, for rational use in the process of radiation and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from China.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment and adverse events.
Detailed Description: The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma and performed chemoradiotherapy from the Oct 2014. The patients will be divided into two groups.Experimental group：esophageal cancer patients with oral megestrol chemoradiation. Megestrol（Yining）：160mg/d，po,5 weeks in total，oen week before chemoradiotherapy and one week after chemoradiotherapy. chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.Control group: Esophageal cancer patients with chemoradiation without oral megestrol.chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment 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, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Ruinuo Jia, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Tanyou Shan, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Xinshuai Wang, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jiachun Sun, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Guoqiang Kong, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhi Yuan, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaoshan Feng, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Zhuo, MD, PhD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jing Ren, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Ruina Yang, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Weijiao Yin, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Wei Wang, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yali Zhang, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Dan Wang, MD
Affiliation: The First Affiliated Hospital of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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