The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
NCT Number: NCT02644408
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.
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Notify Me45 year–75 year
All sexes
Interventional
Phase 3
Luoyang, Henan, 471003, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Megestrol(Yining): 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
Other names: Yining
radiotherapy (radiation): 50Gy in total,2 Gy/d,5d/w.
Other names: radiation
capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 weeks in total or capecitabine(Aibin) plus Oxaliplatin(Aiheng):65mg/m2,d1,8, 22, 29,I.V. or cisplatin: 75mg/m2 d1,29 5-Fu:750mg/m2CIV24h d1-4,d29-32. The 3 regimens were Randomly distributed to patients.
Time frame: 16 weeks
evaluated by EORTC QLQ-C30 questionnaire
Time frame: 16 weeks
complete response(CR)
Time frame: 16 weeks
The First Affiliated Hospital of Henan University of Science and Technology
Other
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