Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V) (NeoART-V)
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|ClinicalTrials.gov Identifier: NCT03093129|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: artesunate Other: placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Active Comparator: 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.
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).
Other Name: Arinate®
Placebo Comparator: 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.
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
- recurrence free survival 2 years after surgery [ Time Frame: 2 years ]The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery
- Recurrence free survival at 5 years [ Time Frame: 5 years ]Recurrence free survival
- Overall survival at 2 and 5 years [ Time Frame: 2-5 years ]Overall survival
- Colon cancer specific death at 2 and 5 years [ Time Frame: 2-5 years ]Colon cancer specific death
- Artesunate drug related toxicity [ Time Frame: 5 years ]drug related toxicity
- Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin) [ Time Frame: 5years ]Pathological assessment
- Surgical morbidity/mortality [ Time Frame: 5years ]Surgical morbidity/mortality
- Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy [ Time Frame: 5 years ]tumour biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093129
|Contact: Le Huu Song, MD, PhDfirstname.lastname@example.org|
|Contact: Bui Tien Sy, MD, PhDemail@example.com|
|108 Military Central Hospital||Recruiting|
|Contact: Le Huu Song, MD, PhD +84 (0) 974845270 firstname.lastname@example.org|
|Contact: Bui Tien Sy, MD, PhD +84 (0) 974552943 email@example.com|
|Principal Investigator: Le Huu Song, MD, PhD|
|Study Director:||Mai Hong Bang, MD,PhD||108 Military Central Hospital|