A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer
NCT ID: NCT02633098
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2017-04-26
2025-10-31
Brief Summary
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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 reduce the proliferation and growth of cancer cells.
Two hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200mg daily or a matching placebo for 14 days prior to surgery. Patients will be followed up closely for 5 years to see if giving artesunate preoperatively reduces the risk of cancer recurring after surgery.
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Detailed Description
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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 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 clinical impact on patient care.
The NeoART trial is a phase II multicentre randomised, double blind, placebo controlled trial (RCT) for patients undergoing primary surgery for Stage II/III colorectal cancers. Patients are randomised (1:1 ratio) to receive either a two week course of neoadjuvant artesunate 200mg once daily or matching placebo. Both patients and health care professionals are blinded to treatment allocation arm to minimise outcome-reporting bias. The primary endpoint of the trial is recurrence free survival two years after surgery. Secondary endpoints include 2 and 5 year overall survival, treatment related toxicity, tolerability and patient quality of life. A translational sub-study looking at predictive and prognostic biomarkers is also planned.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Artesunate
Artesunate 200mg oral tablets once daily for 14 days.
Artesunate 200mg
Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
Matching placebo
Matching placebo oral tablets once daily for 14 days.
Placebo
Matched placebo PO OD for 14 days prior to colorectal resection surgery
Interventions
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Artesunate 200mg
Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
Placebo
Matched placebo PO OD for 14 days prior to colorectal resection surgery
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Professor Sanjeev Krishna, BMBCh, DPhil, ScD
Role: PRINCIPAL_INVESTIGATOR
St George's University Hospitals NHS Foundation Trust
Locations
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Medway Maritime Hospital
Gillingham, Kent, United Kingdom
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Barking, , United Kingdom
Ashford & St Peters Hospital NHS Foundation Trust
Chertsey, , United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, , United Kingdom
St George's University Hospitals NHS Fundation Trust
London, , United Kingdom
Norfolk & Norwich University Hospitlas NHS FT
Norwich, , United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Cheryl Websdale
Role: backup
Sally Potts
Role: backup
Other Identifiers
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15.0154
Identifier Type: -
Identifier Source: org_study_id
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