Evaluating pre-operative artesunate for colorectal cancer
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
This study is testing whether taking an antimalarial drug called artesunate for two weeks before surgery can help prevent cancer from coming back in people with Stage II/III colorectal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St George's, University of London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Gillingham, Kent and 7 other locations) |
| Trial ID | NCT02633098 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and effectiveness of administering artesunate, an antimalarial drug, orally for 14 days before surgery in patients with Stage II/III colorectal cancer. Two hundred patients will be randomly assigned to receive either artesunate or a placebo, with the aim of determining if this treatment can reduce cancer recurrence after surgery. The study will monitor participants for five years to evaluate long-term outcomes. The approach leverages artesunate's established safety profile and potential anticancer properties, which have shown promise in laboratory settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with Stage II/III colorectal cancer who are scheduled for surgical resection and do not require neoadjuvant chemotherapy.
Not a fit: Patients with advanced colorectal cancer requiring immediate chemotherapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a well-tolerated and affordable option to reduce cancer recurrence in colorectal cancer patients undergoing surgery.
How similar studies have performed: While some laboratory studies have indicated the potential of artesunate in cancer treatment, this specific approach in a clinical setting is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Aged 18 or over 2. Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer 3. Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy 4. WHO performance status 0,1 or 2 5. Adequate full blood count: White Cell Count (WCC) \>3.0 x 10\^9 /l; Platelets \>100 x 10\^9/l; Haemoglobin (Hb) \>80g/L 6. Adequate renal function: Glomerular Filtration Rate \>30ml/min by Cockcroft-Gault formula 7. Adequate hepatobiliary function : Bilirubin \< 3 x Upper limit normal 8. 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 adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention 9. Male participants with a partner of childbearing potential must agree to use adequate, medically approved contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention 10. Patient able and willing to provide written, informed consent for the study. Exclusion criteria 1. Contraindication to the use of artesunate due to hypersensitivity 2. Pregnancy or lactation 3. Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film); or agreement of true abstinence from time to consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation methods are not considered acceptable methods) 4. History of immunosuppression 5. History of hearing or balance problems 6. Weight \< 52kg or \> 110kg 7. Other planned intervention, apart from standard of care 8. Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ 9. Lactose intolerance
Where this trial is running
Gillingham, Kent and 7 other locations
- Medway Maritime Hospital — Gillingham, Kent, United Kingdom (Completed)
- Kent Oncology Centre, Maidstone Hospital — Maidstone, Kent, United Kingdom (Completed)
- Barking, Havering and Redbridge University Hospitals NHS Trust — Barking, United Kingdom (Recruiting)
- Ashford & St Peters Hospital NHS Foundation Trust — Chertsey, United Kingdom (Recruiting)
- University Hospitals of Derby and Burton NHS Foundation Trust — Derby, United Kingdom (Recruiting)
- St George's University Hospitals NHS Fundation Trust — London, United Kingdom (Active_not_recruiting)
- Norfolk & Norwich University Hospitlas NHS FT — Norwich, United Kingdom (Recruiting)
- Shrewsbury and Telford Hospital NHS Trust — Shrewsbury, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor Sanjeev Krishna, BMBCh, DPhil, ScD — St George's University Hospitals NHS Foundation Trust
- Study coordinator: Professor Sanjeev Krishna, FRCP, ScD, FMedSci
- Email: s.krishna@sgul.ac.uk
- Phone: ++44(0)208 725 5836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.