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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Artesunate (Trade name : Arinate®) Artemisinins are a family of sesquiterpene trioxane anti-malarial agents derived from Sweet wormwood (Artemisia annua L) that have been used in traditional Chinese medicine for centuries to treat fevers. Artesunate, artemether and arteether are derivatives of artemisinin that are converted into their active metabolite dihydroartemisinin (DHA). Artesunate is approved for the treatment of uncomplicated and multidrug-resistant malaria and is on the WHO list of Essential Medicines (WHO., 2015).
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
108 Military Central Hospital
Hanoi, Vietnam
RECRUITINGrecurrence free survival 2 years after surgery
The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery
Time frame: 2 years
Recurrence free survival at 5 years
Recurrence free survival
Time frame: 5 years
Overall survival at 2 and 5 years
Overall survival
Time frame: 2-5 years
Colon cancer specific death at 2 and 5 years
Colon cancer specific death
Time frame: 2-5 years
Artesunate drug related toxicity
drug related toxicity
Time frame: 5 years
Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)
Pathological assessment
Time frame: 5years
Surgical morbidity/mortality
Surgical morbidity/mortality
Time frame: 5years
Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy
tumour biomarkers
Time frame: 5 years
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