NCT02909114Unknown2 期
Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Jing Jin, M.D.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- local control assessed by RECIST
研究概览
简要总结
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer
详细描述
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.
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
- •18-75 years
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- •Diagnosis by pathological examination
- •Primary lesion is under control by surgery
- •Adequate blood counts:
- •White blood cell count ≥3.5 x 109/L
- •Haemoglobin levels ≥100g/L
- •Platelet count ≥100 x 109/L
- •Creatinine levels ≤1.0× upper normal limit (UNL)
- •Urea nitrogen levels ≤1.0× upper normal limit (UNL)
- •Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL)
- •Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL)
- •Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL)
- •Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL)
排除标准
- •Primary lesion is not under control
- •Pancreatic carcinoma
- •Oligometastases could not be located
- •Pregnancy or breast feeding
- •Symptoms or history of peripheral neuropathy
结局指标
主要结局
local control assessed by RECIST
时间窗: 3 years
次要结局
- >= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0(from radiotherapy start to complete treatment 90 days)
- overall survival(3 years)
研究者
Jing Jin, M.D.
Medical Doctor
Chinese Academy of Medical Sciences
研究点 (1)
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