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

NCT03093129 | Unknown Phase 2 DMC

• 1 other identifier: NeoArt-V
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (7)

• Recurrence free survival at 5 years

  5 years

• Overall survival at 2 and 5 years

  2-5 years

• Colon cancer specific death at 2 and 5 years

  2-5 years

• Artesunate drug related toxicity

  5 years

• Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)

  5years

Study Arms (2)

artesunate

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

artesunate DRUG

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).

Also known as: Arinate®

artesunate

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The 108 Military Central Hospital: lead
• Institute of Tropical Medicine, University of Tuebingen: collaborator

Study Sites (1)

108 Military Central Hospital

Hanoi, Vietnam

RECRUITING

Related Publications (1)

• 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.

  PMID: 26137537 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Mai Hong Bang, MD,PhD

  108 Military Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Le Huu Song, MD, PhD

CONTACT

+84-974845270; lehuusong@108-icid.com

Bui Tien Sy, MD, PhD

CONTACT

+84-974552943; tiensy2015@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD,PhD

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 28, 2017
• Study Start: January 8, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

VN (1)