Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Local Control rate
研究概览
简要总结
To assess the effectiveness of close and intense monitoring on nutritional status of gastrointestinal cancer patients during chemoradiotherapy (CRT), 500 CRT patients diagnosed with gastrointestinal system are going to be recruited into this prospective study. Patient-generated subjective global assessment (PG-SGA) scale and nutrition risk screening (NRS-2002) are used for nutritional assessment at the beginning and the end of CRT; Beside the nutritional parameters, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and gastric cancer module (QLQ-STO22) are used to measure quality of life in patients with gastric cancer while EORTC QLQ-C30 and Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38) give assessment in colorectal cancer. The acute and late radiation toxicities were evaluated based on Conmon terminology criteria (CTC V3.0) and the toxicity criteria of RTOG/EORTC, respectively. Follow-ups every 3-6 months until three years after chemoradiotherapy are involved. Response Evaluation Criteria in Solid Tumors (RECIST) guidelines are used for response assessment. The primary endpoints are 3-year local control, disease-free survival, distant metastasis and overall survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •pregnancy or breast-feeding women
- •serious medical illness
- •baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- •DPD deficiency
结局指标
主要结局
Local Control rate
时间窗: From date of randomization until the date of first documented pelvic failure, assessed up to 3 years
Number of participants with abdominal or pelvic failure after surgery, evaluated using Kaplan-Meier Curve
次要结局
- Disease-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years)
- Overall Survival(From date of randomization until the date of death from any cause, assessed up to 3 years)