search
Back to results

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V) (NeoART-V)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
artesunate
placebo
Sponsored by
The 108 Military Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 108 Military Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

artesunate

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

recurrence 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

Secondary Outcome Measures

Recurrence free survival at 5 years
Recurrence free survival
Overall survival at 2 and 5 years
Overall survival
Colon cancer specific death at 2 and 5 years
Colon cancer specific death
Artesunate drug related toxicity
drug related toxicity
Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)
Pathological assessment
Surgical morbidity/mortality
Surgical morbidity/mortality
Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy
tumour biomarkers

Full Information

First Posted
March 16, 2017
Last Updated
January 8, 2018
Sponsor
The 108 Military Central Hospital
Collaborators
Institute of Tropical Medicine, University of Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT03093129
Brief Title
Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)
Acronym
NeoART-V
Official Title
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The 108 Military Central Hospital
Collaborators
Institute of Tropical Medicine, University of Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
artesunate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
artesunate
Other Intervention Name(s)
Arinate®
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
Primary Outcome Measure Information:
Title
recurrence free survival 2 years after surgery
Description
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
Secondary Outcome Measure Information:
Title
Recurrence free survival at 5 years
Description
Recurrence free survival
Time Frame
5 years
Title
Overall survival at 2 and 5 years
Description
Overall survival
Time Frame
2-5 years
Title
Colon cancer specific death at 2 and 5 years
Description
Colon cancer specific death
Time Frame
2-5 years
Title
Artesunate drug related toxicity
Description
drug related toxicity
Time Frame
5 years
Title
Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)
Description
Pathological assessment
Time Frame
5years
Title
Surgical morbidity/mortality
Description
Surgical morbidity/mortality
Time Frame
5years
Title
Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy
Description
tumour biomarkers
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Le Huu Song, MD, PhD
Phone
+84-974845270
Email
lehuusong@108-icid.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bui Tien Sy, MD, PhD
Phone
+84-974552943
Email
tiensy2015@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Hong Bang, MD,PhD
Organizational Affiliation
108 Military Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
108 Military Central Hospital
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Huu Song, MD, PhD
Phone
+84 (0) 974845270
Email
lehuusong@108-icid.com
First Name & Middle Initial & Last Name & Degree
Bui Tien Sy, MD, PhD
Phone
+84 (0) 974552943
Email
tiensy2015@yahoo.com
First Name & Middle Initial & Last Name & Degree
Le Huu Song, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26137537
Citation
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.
Results Reference
background

Learn more about this trial

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)

We'll reach out to this number within 24 hrs