Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Quality of Life (QoF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients and the medical professionals who cared for them were unaware of the assigned study regimen.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Megestrol and chemoradiotherapy
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.
干预措施: Megestrol（Yining） (Drug)
Megestrol and chemoradiotherapy
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.
干预措施: radiotherapy (Radiation)
Megestrol and chemoradiotherapy
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.
干预措施: chemotherapy (Other)
chemoradiotherapy
chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.
干预措施: radiotherapy (Radiation)
chemoradiotherapy
chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.
干预措施: chemotherapy (Other)
结局指标
主要结局
Quality of Life (QoF)
时间窗: 16 weeks
evaluated by EORTC QLQ-C30 questionnaire
次要结局
- pathological response(16 weeks)
- adverse events(16 weeks)