Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)
NCT ID: NCT03093129
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2018-01-08
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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).
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.
placebo
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
Interventions
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artesunate
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).
placebo
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Institute of Tropical Medicine, University of Tuebingen
OTHER
The 108 Military Central Hospital
OTHER_GOV
Responsible Party
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Le Huu Song
Associate Professor MD,PhD
Principal Investigators
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Mai Hong Bang, MD,PhD
Role: STUDY_DIRECTOR
108 Military Central Hospital
Locations
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108 Military Central Hospital
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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Krishna S, Ganapathi S, Ster IC, Saeed ME, Cowan M, Finlayson C, Kovacsevics H, Jansen H, Kremsner PG, Efferth T, Kumar D. A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer. EBioMedicine. 2014 Nov 15;2(1):82-90. doi: 10.1016/j.ebiom.2014.11.010. eCollection 2015 Jan.
Other Identifiers
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NeoArt-V
Identifier Type: -
Identifier Source: org_study_id
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