NCT03149978Unknown不适用
Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
Zhu Ji1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- TRG
研究概览
简要总结
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •history of primary rectal cancer with distance from anal verge being less than 12 cm;
- •histologically confirmed adenocarcinoma;
- •initial pathological stage of T3 or T4 and/or N+;
- •no history of initial distant metastases;
- •Karnofsky Performance Status score of ≥75
- •≥18 years;≤75 years
- •sign the inform consent
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
结局指标
主要结局
TRG
时间窗: Surgery scheduled 6-8 weeks after the end of chemoradiation
Tumor regression grade
次要结局
- Pathologic Complete Response(Surgery scheduled 6-8 weeks after the end of chemoradiation)
- Local Control rate(From date of randomization until the date of first documented pelvic failure, assessed up to 10 years)
- 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 10 years)
- Overall Survival(From date of randomization until the date of death from any cause, assessed up to 10 years)
- Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0(Up to 2 years)
研究者
Zhu Ji
Professor
Fudan University
研究点 (1)
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