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

Last updated: January 8, 2018
Sponsor: The 108 Military Central Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Colon Cancer; Rectal Cancer

Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT03093129
NeoArt-V
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 or over

  • Histologically proven single primary site colorectal adenocarcinoma

  • Stage II/III colorectal cancer planned for surgical resection and no clinicalindication 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-Gaultformula

  • 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 usingcontraceptive precautions for up to 6 weeks after the last dose of study treatmentintervention

  • Male participants with a partner of childbearing potential must agree to usecontraceptive precautions during and for up to 6 weeks after the last dose of thestudy treatment intervention

  • Patient able and willing to provide written, informed consent for the study

Exclusion

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 exceptionof non-melanomatous skin cancer and carcinoma in situ

  • Lactose intolerance

Study Design

Total Participants: 200
Study Start date:
January 08, 2018
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • 108 Military Central Hospital

    Hanoi,
    Vietnam

    Active - Recruiting

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