A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer

Launched by ST GEORGE'S, UNIVERSITY OF LONDON · Dec 14, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called artesunate, which is typically used to treat malaria, in patients with Stage II/III colorectal cancer. The goal is to see if taking artesunate for 14 days before surgery can help reduce the chances of cancer coming back after the operation. The trial will involve 200 patients who will either receive artesunate or a placebo (a pill that looks the same but has no active medication) for two weeks before their surgery.

To participate in this trial, individuals must be at least 18 years old and have a specific type of colorectal cancer that is operable. They should not have any recent history of other cancers or conditions that would make it unsafe to take artesunate. Participants will be closely monitored for five years after their surgery to track their health and see if artesunate helps prevent cancer recurrence. If you or someone you know is considering joining this trial, it’s important to discuss it with a doctor to understand all the details and eligibility requirements.

Gender

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Eligibility 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