Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Disease-free survival time
研究概览
简要总结
This study will take disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III colorectal cancer
详细描述
The study enrolled 350 patients with stage II high-risk and stage III colorectal cancer who underwent adjuvant chemotherapy (based on a 5-fluorouracil（5-FU） regimen for at least 3 months) and patients who received chemotherapy for less than 3 months. The study will use a large sample, multicenter, randomized, double-blind study. The experimental group was given oral Jianpi Huatan dispensing granule, once a day in the morning and evening, 1 course per 1 month, a total of 3 courses; the control group of oral Chinese medicine formula low dose control granules (including the test group dose 1 /10), 1 time each morning and evening, 1 course per month, for a total of 3 courses.
The patients were followed up once a month during the treatment period and once every 3-6 months after the end of treatment until the patient relapsed, died or the study was over.Some patients in the study will be tested for circulating tumor cells.
Main outcome measures is Disease-free survival time（DFS）and Metastasis recurrence rate in 1 year；Secondary outcome measures：Quality of life score: applied quality of life scale.Metastasis recurrence rate in 2、3years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules. Random sequence was generated by professional statisticians of group leader unit by statistical software. 350 subjects were divided into experimental group and control group according to the ratio of 1:1, 175 cases in each group. Random seeds and random sequences are stored as confidential data in opaque envelopes, and emergency envelopes are handed over to a third party to ensure that patients, researchers and outcome evaluators are unaware of the patient group before blindness is uncovered. After successful screening and signing the informed consent form, the patient can open a random envelope in turn and record the subject's name, hospital number and admission time on the envelope.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria；
- •Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy；
- •Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage；
- •Age 18-80 years, sex unlimited；
- •No recurrence or metastasis by imaging or doctor's clinical judgement；
- •Signed informed consent； Note * According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows:：a.T4;b. Less than 12 lymph nodes were detected；c. preoperative intestinal obstruction, perforation of tumor site；d. poor histological differentiation (except highly unstable microsatellite)；e. neurological invasion and vascular tumor thrombus； f. positive or unknown margin, and insufficient margin safety distance. Phase III：T1-4N1-2M
- •Exclusion criteria:
- •History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix；
- •Combined with severe heart, liver and kidney disease；
- •Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia;
- •The researchers determine that they were not suitable for the study.
排除标准
- 未提供
研究组 & 干预措施
test group
The test group will oral Jianpi Huatan dispensing granule , once a day in the morning and evening, once a month for a course of treatment, a total of three courses.
干预措施: Jianpi Huatan dispensing granule (Drug)
control group
The control group will oral drug:low-dose control granules (containing 1/10 of the dose of the experimental group) , once a day in the morning and evening, once a month for a course of treatment, a total of three courses
干预措施: Jianpi Huatan dispensing granule (Drug)
结局指标
主要结局
Disease-free survival time
时间窗: 3 years
from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.
Metastasis recurrence rate in 1 year
时间窗: 1 year
The ratio of metastasis and recurrence to the patients was observed.
次要结局
- Traditional Chinese Medicine(TCM )symptom grading table(3 months)
- Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale(3 months)
- Edmonton Symptom Assessment Scale( ESAS )(3months)
- Metastasis recurrence rate in 2 years(2 years)
- Metastasis recurrence rate in 3 years(3 years)