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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: artesunate Other: placebo Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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®

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.
Other: placebo
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Recurrence free survival at 5 years [ Time Frame: 5 years ]
    Recurrence free survival

  2. Overall survival at 2 and 5 years [ Time Frame: 2-5 years ]
    Overall survival

  3. Colon cancer specific death at 2 and 5 years [ Time Frame: 2-5 years ]
    Colon cancer specific death

  4. Artesunate drug related toxicity [ Time Frame: 5 years ]
    drug related toxicity

  5. Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin) [ Time Frame: 5years ]
    Pathological assessment

  6. Surgical morbidity/mortality [ Time Frame: 5years ]
    Surgical morbidity/mortality

  7. Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy [ Time Frame: 5 years ]
    tumour biomarkers



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Le Huu Song, MD, PhD +84-974845270 lehuusong@108-icid.com
Contact: Bui Tien Sy, MD, PhD +84-974552943 tiensy2015@yahoo.com

Locations
Vietnam
108 Military Central Hospital Recruiting
Hanoi, Vietnam
Contact: Le Huu Song, MD, PhD    +84 (0) 974845270    lehuusong@108-icid.com   
Contact: Bui Tien Sy, MD, PhD    +84 (0) 974552943    tiensy2015@yahoo.com   
Principal Investigator: Le Huu Song, MD, PhD         
Sponsors and Collaborators
The 108 Military Central Hospital
Institute of Tropical Medicine, University of Tuebingen
Investigators
Study Director: Mai Hong Bang, MD,PhD 108 Military Central Hospital

Publications:
Responsible Party: Le Huu Song, Associate Professor MD,PhD, The 108 Military Central Hospital
ClinicalTrials.gov Identifier: NCT03093129     History of Changes
Other Study ID Numbers: NeoArt-V
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Artesunate
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials