Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- recurrence free survival 2 years after surgery
研究概览
简要总结
This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
详细描述
Colorectal cancer (CRC) is the third most common cancer worldwide and represents a significant health care burden with an incidence of one million new cases per year. In Vietnam, Colorectal cancer is the third most common cause of cancer deaths in men and fourth in women. Artesunate is a safe and effective antimalarial with evidence of anticancer properties across a range of cancer cell lines. Results from a pilot feasibility study in colorectal cancer patients in the UK showed that artesunate was safe and well tolerated. These findings provided the basis for a Phase II clinical trial investigating the effects of neoadjuvant artesunate on progression free survival and overall survival in Stage II/III Colorectal Cancer in Vietnamese Patients.
Artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over
- •Histologically proven single primary site colorectal adenocarcinoma
- •Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy
- •WHO performance status 0,1 or 2
- •Adequate full blood count: White Cell Count (WCC) >3.0 x 109 /l; Platelets >100 x 109/l; Haemoglobin (Hb) >8g/dL
- •Adequate renal function : Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula
- •Adequate hepatobiliary function : Bilirubin < 3 x Upper limit normal
- •Female participants of child bearing potential must have a negative pregnancy test < 72 hours prior to initiating study intervention and agree to avoid pregnancy using contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention
- •Male participants with a partner of childbearing potential must agree to use contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention
- •Patient able and willing to provide written, informed consent for the study
排除标准
- •Contraindication to the use of artesunate due to hypersensitivity
- •Pregnancy or lactation
- •History of immunosuppression
- •History of hearing or balance problems
- •Weight < 42 kg or > 110 kg
- •Other planned intervention, apart from Vietnamese standard of care
- •Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ
- •Lactose intolerance
研究组 & 干预措施
artesunate
Patients will receive 200 mg artesunate (Arinate®) per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery.
干预措施: artesunate (Drug)
placebo
Patients will receive matching placebo tablets per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery.
干预措施: placebo (Other)
结局指标
主要结局
recurrence free survival 2 years after surgery
时间窗: 2 years
The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery
次要结局
- Colon cancer specific death at 2 and 5 years(2-5 years)
- Artesunate drug related toxicity(5 years)
- Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)(5years)
- Overall survival at 2 and 5 years(2-5 years)
- Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy(5 years)
- Recurrence free survival at 5 years(5 years)
- Surgical morbidity/mortality(5years)
研究者
Le Huu Song
Associate Professor MD,PhD
The 108 Military Central Hospital