Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Two-year disease-free survival (DFS)
研究概览
简要总结
This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
详细描述
Subjects in the intervention group will be treated with XLJDOD compound granule. Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon carcinoma confirmed by pathology.*
- •*Preoperative endoscopy showed that the distal end of the tumor was ≥12cm from the anal margin. If the patient did not undergo endoscopic examination before surgery, the distance of the tumor from the anal margin was ≥12cm according to the results of intraoperative examination or preoperative imaging examination.
- •Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). *
- •*4 cycles of CAPOX (capecitabine and oxaliplatin), 6 cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or 4 cycles of single agent-5-FU, etc.
- •Within 3 months after the completion of adjuvant chemotherapy.
- •Patients with Stage IIIB or IIIC disease.*
- •*IIIB: T3-T4aN1/N1cM0, T2-T3N2aM0 and T1-T2N2bM0, IIIC: T4aN2aM0, T3-T4aN2bM0 and T4bN1-N2M0, as defined by the American Joint Committee on Cancer (AJCC) 8th edition).
- •Aged 20-80 years, men or women.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •With no radiographic evidence of tumor recurrence.
- •Sign the informed consent form.
排除标准
- •Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
- •Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
- •Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
- •Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
- •Allergic to the ingredients of XLJDOD.
- •Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study, including pregnancy, plan to be pregnant, lactation and psychiatric disorders (schizophrenia, depression, and obsessive-compulsive disorder, etc.).
- •Suspected or confirmed history of alcohol and drug abuse.
- •Patients with other conditions considered by the investigator should not participate in the study.
- •Patients who have recently participated in or are currently participating in other clinical trials of drugs.
研究组 & 干预措施
intervention group
Subjects in the intervention group will be treated with XLJDOD compound granule.
干预措施: XLJDOD compound granule (Drug)
control group
Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
干预措施: placebo (XLJDOD mimetic agent) (Drug)
结局指标
主要结局
Two-year disease-free survival (DFS)
时间窗: Assess once 24 months after randomization
2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.
次要结局
- Three-year disease-free survival (DFS)(Assess once 36 months after randomization)
- One, two, three-year relapse rate (RR)(Assess at month 12, 24, 36 after randomization)
- Three-year survival rate(Assess once 36 months after randomization)
- Overall survival (OS)(Observation to the end of the study，assessed up to 24 months)
- Changes in total score on the EORTCQLQ-C30 Scale(Measurement will be performed at baseline and month 6, 12 ,18 ,24, 36.)
- Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)(Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.)