Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- circulating tumor cells level changes after radiotherapy
研究概览
简要总结
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in 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
- 是
入选标准
- •Histologically verified rectal carcinoma
- •Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
- •the distance from anal verge <= 12cm
- •with or without metastasis
- •Age 18-75 years old
- •ECOG PS 0-2
- •No previous chemotherapy or radiotherapy for rectal carcinoma
- •Written informed consent
排除标准
- •no histologically verified rectal carcinoma
- •rectal cancer with stage I
- •distance from verge >12cm
- •age <=18 or >=75 years old
- •performed previously chemotherapy or radiotherapy
- •infection diseases within three months
- •serious other diseases
- •no written informed consent
研究组 & 干预措施
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
干预措施: radiation therapy (Radiation)
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
干预措施: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw) (Drug)
结局指标
主要结局
circulating tumor cells level changes after radiotherapy
时间窗: 3 years
次要结局
- serum carcinoembryonic antigen (CEA) level(3 years)
- pathological response (tumor regression grade)if surgery(3 years)
- overall survival(3 years)
- RECIST-based tumor response at 10 week after radiotherapy(3 years)
- disease-free survival(3 years)
研究者
Zhen Zhang
director of radiotherapy department in Fudan university shanghai cancer center
Fudan University