A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Percentage of Recent Weight Loss
研究概览
简要总结
This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.
详细描述
This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.
All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. The primary endpoint is percentage of recent weight loss at the end of CCRT. The secondary endpoints are nutrition status, objective response rate, overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Estimated life expectancy of at least 6 months
- •No contraindications for chemotherapy or radiotherapy
- •Patients and their family signed the informed consents
排除标准
- •Severe gastrointestinal impairment or enteral nutrition intolerance
- •Severe vomiting, gastrointestinal bleeding or intestinal obstruction
- •Severe malnutrition
- •Patients with contraindications for percutaneous endoscopic gastrostomy, including uncorrected coagulopathy or thrombocytopenia, varices caused by portal hypertension, or other gastric diseases
- •Not suitable for this study judged by researchers
结局指标
主要结局
Percentage of Recent Weight Loss
时间窗: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
次要结局
- Overall survival(3 years)
- Change in nutrition status assessed by blood test(1 year)
- Quality of life measured by WHO Quality of Life-100 questionnaire(1 year)
- Rate of grade 3-4 radiation esophagitis(1 year)
- Rate of grade 3-4 bone marrow suppression(1 year)
- Changes of participants' intestinal flora assessed by blood, urine and stool test(1 year)
- Rate of grade 3-4 radiation pneumonitis，(1 year)
- Objective response rate(2 months)
研究者
Hui Liu
Professor
Sun Yat-sen University