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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
Sponsor:
Collaborator:
Institute of Tropical Medicine, University of Tuebingen
Information provided by (Responsible Party):
Le Huu Song, The 108 Military Central Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)
Official Title  ICMJE Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: 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).

    Other Name: Arinate®
  • Other: placebo
    The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: artesunate
  • 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.
    Intervention: Other: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Le Huu Song, MD, PhD +84-974845270 lehuusong@108-icid.com
Contact: Bui Tien Sy, MD, PhD +84-974552943 tiensy2015@yahoo.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093129
Other Study ID Numbers  ICMJE NeoArt-V
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Le Huu Song, The 108 Military Central Hospital
Study Sponsor  ICMJE The 108 Military Central Hospital
Collaborators  ICMJE Institute of Tropical Medicine, University of Tuebingen
Investigators  ICMJE
Study Director: Mai Hong Bang, MD,PhD 108 Military Central Hospital
PRS Account The 108 Military Central Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP