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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The 108 Military Central Hospital
• Collaborator: Institute of Tropical Medicine, University of Tuebingen
• Treatments: Artesunate

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