Colorectal CancerPhase 2NeoARTNCT02633098
A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer
A Phase 2 study testing Artesunate 200mg in people with Colorectal Cancer and Bowel Cancer, run by St George's, University of London at 8 sites in United Kingdom.
Trial 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 Stage II/III colorectal cancer. Artesunate is an established antimalarial drug with an excellent safety profile, is well tolerated and affordable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Bowel Cancer
- What is being tested?
- Artesunate 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 26 Apr 2017to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer
- 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 10^9 /l; Platelets >100 x 10^9/l; Haemoglobin (Hb) >80g/L
- Adequate renal function: Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula
Show all 10Show fewer
- 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 adequate, medically approved 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 adequate, medically approved 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.
Who cannot join
- Contraindication to the use of artesunate due to hypersensitivity
- Pregnancy or lactation
- 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)
- History of immunosuppression
- History of hearing or balance problems
- Weight < 52kg or > 110kg
Show all 9Show fewer
- Other planned intervention, apart from 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites, 5 recruiting
- Recruiting
Barking, Havering and Redbridge University Hospitals NHS Trust
Barking
Nirooshun Dr Rajendran, 01708 435000 ext. 3615, nirooshun.rajendran@bhrhospitals.nhs.uk
Alison Ray, 01708 435000 ext. 3615, alison.ray@bhrhospitals.nhs.uk
- Recruiting
Ashford & St Peters Hospital NHS Foundation Trust
Chertsey
Pasha Mr Nisar, 01932 722318, pasha.nisar@asph.nhs.uk
Victoria Frost, 01932 723534, victoria.frost@asph.nhs.uk
- Recruiting
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE
Stelios Vakis, 01283 566333, s.vakis@nhs.net
Helen Cox, 01283 56633, helena.cox1@nhs.net
- Completed
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY
- Active, not recruiting
St George's University Hospitals NHS Fundation Trust
London, SW17 0RE
- Completed
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, ME16 9QQ
- Recruiting
Norfolk & Norwich University Hospitlas NHS FT
Norwich, NR4 7UY
Adam Stearns, 01603 287372, adam.stearns@nnuh.nhs.uk
Cheryl Websdale, 01603 288894
- Recruiting
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury
Jon Mr Lacy-Colson, 01743 261000 ext. 1460, jon.lacy-colson@sath.nhs.uk
Sally Potts, 01743 261000 ext. 1692
About this study
Official title: Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
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 Stage II/III 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 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.
Read the detailed description
Artesunate is an established antimalarial drug belonging to the artemisinin class of drugs, has an excellent safety profile, is well tolerated and affordable. In last two decades, artemisinins have shown potent and broad anticancer properties in a range of cell lines and animal models, supporting the hypothesis that artemisinins have the potential to be an effective anti-cancer therapy. Multiple potential mechanisms of action include anti-proliferative effects through cell-cycle disruption, reactive oxygen species (ROS) -induced DNA damage, induction of apoptosis, anti-angiogenesis, immunomodulation and induced radiosensitivity.
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
- Colorectal Cancer, Bowel Cancer
- Being tested
- Artesunate 200mg, Placebo
- Keywords
- Artesunate, Artemisinins, Antimalarial, Neoadjuvant, Pre-operative
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate 200mgDrug
Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
PlaceboDrug
Matched placebo PO OD for 14 days prior to colorectal resection surgery
| Study group | Role | What they receive |
|---|---|---|
| Artesunate | Experimental | Artesunate 200mg oral tablets once daily for 14 days. Receives: Drug: Artesunate 200mg |
| Matching placebo | Placebo comparator | Matching placebo oral tablets once daily for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival at 2 years
Measured: 2 years following study randomisation.
Secondary outcomes (39)
Recurrence free survival at 5 years
Measured: 5 years from study randomisation
Overall survival at 2 and 5 years
Measured: 2 and 5 years from study randomisation
Colon cancer specific death at 2 and 5 years
Measured: 2 and 5 years from study randomisation
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 7 following start of study intervention (artesunate/matching placebo)
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 14 following start of study intervention (artesunate/matching placebo)
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 42 following start of study intervention (artesunate/matching placebo)
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 7 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 14 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment at Day 42 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 6 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 12 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 18 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 24 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 30 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 36 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 42 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 48 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 54 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Assessment 60 months following study intervention
Pathological assessment of tumour regression (involvement of lymph nodes; serosa; resection margin)
Measured: Post surgical pathology review (following Day 14 of study intervention)
Patient quality of life
Using validated quality of life self-administered questionnaires
Measured: Assessment at Day 1 of study intervention
Patient quality of life
Using validated quality of life self-administered questionnaires
Measured: Assessment at Day 7 of study intervention
Patient quality of life
Using validated quality of life self-administered questionnaires
Measured: Assessment at Day 14 of study intervention
Patient quality of life
Using validated quality of life self-administered questionnaires
Measured: Assessment at Day 42 of study intervention
Surgical complications
Number of patients with surgery related adverse events as assessed by CTCAE v4.0
Measured: From time of surgery up to 3 months post surgery
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Measured: Assessment at Day 1 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Measured: Assessment at Day 7 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Measured: Assessment at Day 14 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Measured: Assessment at Day 42 of study intervention
Immunohistochemical analyses of paraffin-embedded tumour sections to assess Kirsten rat sarcoma viral oncogene homolog (Kras) mutation status
Number of patients with Kras mutant tumours
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour sections to assess Mismatch Repair (MMR) status
Number of patients with Mismatch Repair (MMR) mutant tumours
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation status
Number of patients with BRAF mutant tumours
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor (PDGF) expression
Number of patients whose tumours show PDGF upregulation/downregulation following treatment intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor receptor (PDGFR) expression
Number of patients whose tumours show PDGFR upregulation/downregulation following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Vascular endothelial Growth Factor (VEGF) expression
Number of patients whose tumours show VEGF upregulation/downregulation following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour on Vascular endothelial Growth Factor Receptor (VEGFR) expression
Number of patients whose tumours show VEGFR upregulation/downregulation following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Determination of proliferative activity (Ki-67 staining, Cluster of Differentiation 31 protein (CD31) staining)
Number of patients whose tumours show an increase or reduction in proliferation markers Ki67 and CD31 following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Determination of activation of the Deoxyribonucleic acid damage response (DDR) pathway
Number of patients whose tumour samples show activation of the DDR pathway following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Wnt/β-catenin proliferation pathway protein expression (e.g. c-myc and cyclinD1 proteins)
Number of patients who show an increase or a decrease in expression of proteins involved in the Wnt/β-catenin proliferation pathway (e.g. c-myc and cyclinD1 proteins) following study intervention
Measured: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start26 Apr 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Sanjeev Krishna, BMBCh, DPhil, ScD, Principal investigator, St George's University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633098
- Sponsor's protocol ID
- 15.0154
- Acronym
- NeoART
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2015
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02633098
- Acronym / sponsor ID
- NeoART / 15.0154
- Conditions
- Colorectal Cancer, Bowel Cancer
- Keywords
- Artesunate, Artemisinins, Antimalarial, Neoadjuvant, Pre-operative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Stage II/III 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 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.
Detailed description
Artesunate is an established antimalarial drug belonging to the artemisinin class of drugs, has an excellent safety profile, is well tolerated and affordable. In last two decades, artemisinins have shown potent and broad anticancer properties in a range of cell lines and animal models, supporting the hypothesis that artemisinins have the potential to be an effective anti-cancer therapy. Multiple potential mechanisms of action include anti-proliferative effects through cell-cycle disruption, reactive oxygen species (ROS) -induced DNA damage, induction of apoptosis, anti-angiogenesis, immunomodulation and induced radiosensitivity.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artesunate | Experimental | Drug: Artesunate 200mgArtesunate 200mg oral tablets once daily for 14 days. |
| Matching placebo | Placebo comparator | Drug: PlaceboMatching placebo oral tablets once daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 or over
- Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer
- 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 10^9 /l; Platelets >100 x 10^9/l; Haemoglobin (Hb) >80g/L
Key exclusion criteria (9 listed)
- Contraindication to the use of artesunate due to hypersensitivity
- Pregnancy or lactation
- 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)
- History of immunosuppression
- History of hearing or balance problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate 200mgArtesunate 200mg PO OD for 14 days prior to colorectal resection surgery | Drug | Artesunate |
| PlaceboMatched placebo PO OD for 14 days prior to colorectal resection surgery | Drug | Matching placebo |
Primary outcome
Recurrence free survival at 2 years
Time frame: 2 years following study randomisation.
39 secondary outcomes
Recurrence free survival at 5 years
Time frame: 5 years from study randomisation
Overall survival at 2 and 5 years
Time frame: 2 and 5 years from study randomisation
Colon cancer specific death at 2 and 5 years
Time frame: 2 and 5 years from study randomisation
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 7 following start of study intervention (artesunate/matching placebo)
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 14 following start of study intervention (artesunate/matching placebo)
Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 42 following start of study intervention (artesunate/matching placebo)
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 7 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 14 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment at Day 42 following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 6 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 12 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 18 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 24 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 30 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 36 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 42 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 48 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 54 months following study intervention
Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Assessment 60 months following study intervention
Pathological assessment of tumour regression (involvement of lymph nodes; serosa; resection margin)
Time frame: Post surgical pathology review (following Day 14 of study intervention)
Patient quality of life
Time frame: Assessment at Day 1 of study intervention
Patient quality of life
Time frame: Assessment at Day 7 of study intervention
Patient quality of life
Time frame: Assessment at Day 14 of study intervention
Patient quality of life
Time frame: Assessment at Day 42 of study intervention
Surgical complications
Time frame: From time of surgery up to 3 months post surgery
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Time frame: Assessment at Day 1 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Time frame: Assessment at Day 7 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Time frame: Assessment at Day 14 of study intervention
Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy
Time frame: Assessment at Day 42 of study intervention
Immunohistochemical analyses of paraffin-embedded tumour sections to assess Kirsten rat sarcoma viral oncogene homolog (Kras) mutation status
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour sections to assess Mismatch Repair (MMR) status
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation status
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor (PDGF) expression
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor receptor (PDGFR) expression
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour for Vascular endothelial Growth Factor (VEGF) expression
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Immunohistochemical analyses of paraffin-embedded tumour on Vascular endothelial Growth Factor Receptor (VEGFR) expression
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Determination of proliferative activity (Ki-67 staining, Cluster of Differentiation 31 protein (CD31) staining)
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Determination of activation of the Deoxyribonucleic acid damage response (DDR) pathway
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Wnt/β-catenin proliferation pathway protein expression (e.g. c-myc and cyclinD1 proteins)
Time frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Sanjeev Krishna, BMBCh, DPhil, ScD principal investigator
St George's University Hospitals NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate 200mg in people with Colorectal Cancer and Bowel Cancer, run by St George's, University of London at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Sanjeev Krishna, FRCP, ScD, FMedSci (++44(0)208 725 5836, s.krishna@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival at 2 years (time frame: 2 years following study randomisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.