NeoART version 1.0
Research type
Research Study
Full title
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer (NeoART trial)
IRAS ID
188869
Contact name
Debbie Rolfe
Contact email
Sponsor organisation
St George's University of London
Eudract number
2015-004322-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
This study evaluates the safety and effectiveness of pre-operative artesunate given orally once a day for 14 days prior to surgery in patients with operable colorectal cancer.
Artesunate is an established antimalarial drug with an excellent safety profile, is well tolerated and affordable. A number of laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can potentially reduce the activity of cancer cells.Despite a multi-modality treatment approach to colorectal cancer, 5 year overall survival does not currently exceed 60%. Neoadjuvant (pre-operative) therapy may be more effective at eradicating micrometastases compared to adjuvant therapy delivered following the delay and immunological stress of surgery. However current neoadjuvant chemotherapy regimens are often associated with significant side effects and may result in a delay in primary surgery whilst patients recover. A well tolerated, affordable, novel anticancer agent that could be given to patients whilst they wait for surgery, without causing a surgical delay due to treatment related toxicity, would have a significant positive clinical impact on patient care.
Patients in our study will be randomly allocated to receive oral artesunate daily for 14 days or a matching placebo. Patients will be followed up closely for 5 years to see if giving artesunate preoperatively reduces the risk of cancer returning after treatment.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0585
Date of REC Opinion
26 Apr 2016
REC opinion
Favourable Opinion