A One-arm, Prospective Study Comparing the Effects of Different Body Composition on the Survival of Patients Undergoing Radical Concurrent Chemoradiotherapy for Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Skeletal muscle depletion and sarcopenia are the most typical features of cachexia, which occurs in 80% of patients with advanced esophageal cancer. Skeletal muscle consumption is an independent factor for poor prognosis, which negatively affects therapeutic toxicity, length of hospital stay, quality of life, complications, infection, and survival. The vast majority of patients had already experienced severe weight loss and skeletal muscle loss before the treatment began. During the concurrent chemoradiotherapy period, the intensity and long cycle of treatment, the toxic and side effects of treatment and the occurrence of radiation esophagitis would further lead to the increased demand for energy and decreased intake of patients, thus leading to continuous weight loss. Based on the previous literature, we suggest that baseline body composition has a significant impact on nutritional status, the incidence of adverse reactions, and survival during treatment. This research mainly for the thorough chemoradiation in patients with esophageal cancer, analysis treatment precursor composition, including skeletal muscle index, visceral fat area, body fat percentage and other parameters on the side reaction of chemoradiation, nutritional status and the influence of survival, and observe the baseline body composition and cure after 1 month of body composition changes of the impact on the survival time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Voluntary participation and face to face signed informed consent;
- •18 -- 75 years old, gender unlimited;
- •The histological diagnosis was esophageal squamous cell carcinoma, and the clinical staging was stage II-IVA (according to AJCC stage 8, pre-treatment clinical staging was: CT1N2-3M0, CT2-4BN0-3M0).
- •Initial treatment patients receiving radical concurrent chemoradiotherapy; Immunotherapy with or without combination;
- •The primary tumor can be evaluated;
- •No distant metastasis;
- •No serious abnormal function of blood system, heart, lung, liver and kidney or immune deficiency;
- •Hemoglobin (Hb) ≥9 g/dL; White blood cell (WBC) ≥3×109/L; Neutrophils (ANC)≥1.5×109/L; Platelet (PT)≥100×109/L;
- •Bilirubin < 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and alanine aminotransferase (AST) ≤2.5 times the upper limit of normal;
- •Serum creatinine ≤1.5 times the upper limit of normal value;
- •The willingness of men or women of reproductive age to use contraception in the trial;
- •Physical condition score ECOG 0 ~ 2;
- •The expected survival time was >3 months.
排除标准
- •Patients who lacked an evaluation of CT body composition within 15 days prior to treatment initiation;
- •Patients with severe intestinal function damage or inability to tolerate intestinal nutrition;
- •The digestive tract is severely obstructed, unable to take food orally and unable/unwilling to undergo nasogastric tube or percutaneous gastrostomy;
- •Previous surgery, chemoradiotherapy or bio-targeted therapy for esophageal cancer;
- •Previous history of malignant tumor.
结局指标
主要结局
overall survival
时间窗: one month
To evaluate the effect of human components on the overall survival of patients with esophageal cancer undergoing radical concurrent chemoradiotherapy
次要结局
未报告次要终点