Retrospective-Prospective Cohort Study Effectiveness of Comprehensive Therapy of TCM to Relieving the Risk of Recurrence and Metastasis for Stage II & III Colorectal Cancer Based on Conventional Western Medicine Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The recurrence and metastasis rates for 1、2、3、4 and 5-year.
研究概览
简要总结
Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II & III colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way.
If the study shows a positive result, a pragmatic randomized controlled study with prospective, multi-centre and large-sample design will be given continuously. The aim is to establish recommended programs suggested by CTTCM strategies under conventional Western medicine therapy (CWMT) for stage II & III colorectal cancer.
详细描述
CTTCM: taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least.
CWMT: with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).
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
- •Patient who is diagnosed colorectal cancer by patho& cytologic diagnosis since accepting radical operation within half a year.
- •Stage II or III colorectal cancer.
- •18-75 yr.
- •Being able to participate and sign the informed consent.
排除标准
- •Pregnant woman, Psychotic.
- •Patient who put together with other cancer.
- •Existed serious complaint and functional disturbance (impairment) with non-tumorous in arch-organ.
- •Reactiveness cerebrovascular disease (CVD) .
- •Uncontrolled infection and metabolic disease.
- •One item of tumor marks is progressed, and it still is progressed when patient recheck.
- •Tumor that it is neo-occurred in each organ or pelvic cavity or abdominal cavity without definite patho-quality.
结局指标
主要结局
The recurrence and metastasis rates for 1、2、3、4 and 5-year.
时间窗: one year
次要结局
- Survival index: the survival rate for1、2、3、4 and 5-year.(one year)