NCT02399306已完成3 期
A Prospective, Multicenter, Randomized Controlled Study to Compare Chemoradiotherapy With or Without Enteral Nutrition Intervention for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Body Weight Change from baseline to the end of treatment
研究概览
简要总结
This is a randomized, prospective, multicenter study.
详细描述
This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.
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
- 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
- •18 to 75 years old
- •male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
- •Clinical stage II or stage III
- •Karnofsky performance score(KPS) ≧70
- •Estimated life expectancy of at least 12 weeks
- •Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Patients have good compliance to treatment and follow-up of acceptance
- •Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value
- •the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications
排除标准
- •Patients with severely bowel function impaired or can not tolerate enteral nutrition
- •Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
- •Patients have no risk of malnutrition
- •Patients have severe malnutrition (weight loss >10% or <30 g/L, BMI<18.5 kg/m2 or hemoglobin<90 g/L before the treatment
- •Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
- •Patients can not tolerate chemotherapy and radiotherapy
- •Patients who have distant metastasis
- •The primary tumor or lymph node already received surgical treatment (except for biopsy);
- •Patient who received radiotherapy for primary tumor or lymph node;
- •Patient who received chemotherapy or immunotherapy;
- •Patient who suffered from other malignant tumor;
- •Patient who have taken other drug test within 1 month;
- •Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
- •Subject with a severe allergic history or idiosyncratic;
- •Subject with severe pulmonary and cardiopathic disease history;
- •Refuse or incapable to sign the informed consent form of participating this trial;
- •Drug abuse or alcohol addicted;
- •Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;
研究组 & 干预措施
Arm A
Experimental
chemoradiotherapy with Enteral Nutrition intervention
干预措施: Enteral nutrition (Drug)
Arm A
Experimental
chemoradiotherapy with Enteral Nutrition intervention
干预措施: radiotherapy (Radiation)
Arm B
Placebo Comparator
chemoradiotherapy
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Body Weight Change from baseline to the end of treatment
时间窗: up to 1 month after the treatment
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
次要结局
- Blood biochemical examination(up to 1 month after the treatment)
- Maximum Body Weight Change during treatment(up to 1 month after the treatment)
- Grade 3-5 toxicity(up to 1 month after the treatment)
- Overall Survival(at least 2 years)
- Completion rate of chemoradiotherapy(up to 1 month after the treatment)
- short-term effect(up to 1 month after the treatment)
研究者
LI TAO
Section Head
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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