Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Conditions
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Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Megestrol（Yining）
* Radiation: radiotherapy
* Other: chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-75years old Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0 The patients have not received the surgery or chemo-radiotherapy. Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5*N,Cr≤1.5*N. performance status score 0-2 Exclusion Criteria: Pregnant, lactating women Oxaliplatin or fluorouracil Allergy or metabolic disorders Radiotherapy contraindications History of organ transplantation Brain metastasis The peripheral nervous system disorders Severe infection Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. Other malignant tumor in recent 5 years.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megestrol and chemoradiotherapy<br>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. | Drug: Megestrol（Yining）<br>* Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.<br>* Other names: Yining;Radiation: radiotherapy<br>* radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.<br>* Other names: radiation;Other: chemotherapy<br>* 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.<br>|
| Active Comparator: chemoradiotherapy<br>chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w. | Radiation: radiotherapy<br>* radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.<br>* Other names: radiation;Other: chemotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoF) | evaluated by EORTC QLQ-C30 questionnaire | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological response | complete response(CR) | 16 weeks | 
| adverse events |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol