Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Completion Rate of 8-cycle Adjuvant Chemotherapy
研究概览
简要总结
This study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM) 'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of 8-cycle CapeOX chemotherapy in patients with stage II (high-risk)& III colon cancer;(2) evaluate the efficacy of the TCM-TSKSR on adverse events of CapeOX chemotherapy and it's impact on patients' quality of life (QoL).A randomized,double-blinded,placebo-controlled clinical trial including seven centers will be conducted in Mainland China.The study will enroll patients with stage II (high-risk)& III colon cancer who have completed radical surgery and are going to receive CapeOX chemotherapy.All participants will receive chemotherapy as prescribed by their treating physicians and be randomly assigned to either concurrent use of TCM-TSKSR or placebo.
详细描述
CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m^2 IV on 1st day and Capecitabine 1000mg/m^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reductions,treatment delays or even discontinuation among cancer patients. According to IDEA study,the completion rate of 8-cycle CapeOX chemotherapy in colorectal cancer patients is 64%,which means that nearly 4 in 10 patients could not complete adjuvant chemotherapy as planned,which may negatively impact patients' survival outcomes.Some prior studies have shown that TCM can improve patients' symptom control and QoL during adjuvant chemotherapy,which may further improve the completion of adjuvant chemotherapy. However,there is a lack of definitive evidence to evaluate the effects of TCM in stage II(high-risk)& III colon cancer patients who receive adjuvant chemotherapy after radical surgery.The study will be conducted between 2018 and 2021.Four hundred participants will be enrolled and randomly assigned to either the experimental group or the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 with pathological diagnosis of colon cancer; no residual tumor at the resection margin.
- •tumor-node-metastasis(TNM)Stage II (high-risk)or III colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual. High-risk stage II disease is characterized by at least one of the following:
- •inadequately sampled nodes (<12 lymph nodes),
- •clinical presentation with bowel obstruction or perforation,
- •poorly differentiated histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),
- •lymphovascular invasion,perineural invasion(PNI).
- •Underwent radical surgery no more than six weeks ago and plan to start chemotherapy.
- •Have not been enrolled in other therapeutic clinical trials within the near 30 days.
- •Age between 18 to 75 years; All genders; Eastern Cooperative Oncology Group - performance status(ECOG-PS)from 0 to 2; Women who are pregnant, lactating or of reproductive age are not eligible, while those of reproductive age using secure contraceptives are eligible.
- •No history of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 5 years.
- •Laboratory testing: blood routine examination: WBC≥3.5×109/L，NEUT≥1.5×109/L,PLT≥100×109/L,HGB≥90g/L;biochemical tests:TBIL≤1.5×ULN,AST(SGOT),ALT(SGPT)≤2.5×ULN,Scr≤1.5×ULN;CEA after surgery was normal.
- •Consented.
- •Agree not to be enrolled in other interventional studies during the research.
排除标准
- •Patients not suitable for chemotherapy of CapeOX ,which will be determined by the investigator or the attending physician.
- •Clinically relevant cardiovascular and/or cerebrovascular disease,active hepatitis,severe abnormalities in liver/ renal function tests.
- •Known allergy to any of the components of study drug.
- •Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition.
- •Malabsorption or diseases that affect the absorption.
- •Unstable situations or situations that may endanger the safety of patients and their compliance, such as severe mental illness,schizophrenia.
- •Colostomy
研究组 & 干预措施
TCM group
Tonifying Spleen and Kidney Sequential Regimen(TSKSR) will be prescribed to the participants in each course of chemotherapy.
干预措施: Tonifying Spleen and Kidney Sequential Regimen (Drug)
Placebo group
Placebo of Tonifying Spleen and Kidney Sequential Regimen(TSKSR)similar in color,smell and texture with TSKSR will be prescribed to participants in each course of chemotherapy.
干预措施: Placebo of 'Tonifying Spleen and Kidney Sequential Regimen (Drug)
结局指标
主要结局
Completion Rate of 8-cycle Adjuvant Chemotherapy
时间窗: 6months
Completion Rate of 8-cycle Adjuvant Chemotherapy=number of participants completing 8-cycle adjuvant chemotherapy/number of participants randomized to each group\*100%
次要结局
- Relative Dose Intensity (RDI) of Adjuvant Chemotherapy(6months)
- Proportion of Modifications of Time(6months)
- Time of Dose Reductions of Adjuvant Chemotherapy for the First Time(6months)
- Completion Rate of Adjuvant Chemotherapy of Each Participant(6months)
- Time to Treatment Failure,TTF(6months)
- Incidence of AEs(6months)
- Proportion of Salvage Treatment(6months)
- Time of Dose Reductions of Adjuvant Chemotherapy for the Second Time(6months)
- Incidence of a Chemo-induced Grade 2 Diarrhea(6 months)
- Changes of Participants' ESAS Score(6 months)
- Completion Rate of 4-cycle Adjuvant Chemotherapy(3months)
- Incidence of a Chemo-induced Grade 3-4 Nausea/Vomiting(6 months)
- Changes of TCM Symptoms Score(6months)
- Changes of Spleen Deficiency Scale Score(6months)
- Changes of Kidney Deficiency Scale Score(6months)
- Changes of Participants' FACT-C Score(6months)
- Incidence of SAEs(6months)