Colorectal CancerPhase 2NeoART-VNCT03093129
Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)
A Phase 2 study testing artesunate in people with Colorectal Cancer, run by The 108 Military Central Hospital at 1 site in Vietnam.
Trial summary
This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- artesunate
- 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
- 1 siteVietnam
- Study dates
- 8 Jan 2018to Dec 2022
- 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 to 70 years
- 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
- 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 109 /l; Platelets >100 x 109/l; Haemoglobin (Hb) >8g/dL
- Adequate renal function : Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula
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- 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 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 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
- History of immunosuppression
- History of hearing or balance problems
- Weight < 42 kg or > 110 kg
- Other planned intervention, apart from Vietnamese 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
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
108 Military Central Hospital
Hanoi
Le Huu Song, MD, PhD, +84 (0) 974845270, lehuusong@108-icid.com
Bui Tien Sy, MD, PhD, +84 (0) 974552943, tiensy2015@yahoo.com
About this study
Official title: Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients
This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide and represents a significant health care burden with an incidence of one million new cases per year. In Vietnam, Colorectal cancer is the third most common cause of cancer deaths in men and fourth in women. Artesunate is a safe and effective antimalarial with evidence of anticancer properties across a range of cancer cell lines. Results from a pilot feasibility study in colorectal cancer patients in the UK showed that artesunate was safe and well tolerated. These findings provided the basis for a Phase II clinical trial investigating the effects of neoadjuvant artesunate on progression free survival and overall survival in Stage II/III Colorectal Cancer in Vietnamese Patients.
Artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
- Conditions
- Colorectal Cancer
- Being tested
- artesunate, placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunateDrug
Also called Arinate®
Artesunate (Trade name : Arinate®)
Artemisinins are a family of sesquiterpene trioxane anti-malarial agents derived from Sweet wormwood (Artemisia annua L) that have been used in traditional Chinese medicine for centuries to treat fevers. Artesunate, artemether and arteether are derivatives of artemisinin that are converted into their active metabolite dihydroartemisinin (DHA). Artesunate is approved for the treatment of uncomplicated and multidrug-resistant malaria and is on the WHO list of Essential Medicines (WHO., 2015).
placeboOther
The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
| Study group | Role | What they receive |
|---|---|---|
| artesunate | Active comparator | Patients will receive 200 mg artesunate (Arinate®) per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery. Receives: Drug: artesunate |
| placebo | Placebo comparator | Patients will receive matching placebo tablets per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence free survival 2 years after surgery
The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery
Measured: 2 years
Secondary outcomes (7)
Recurrence free survival at 5 years
Recurrence free survival
Measured: 5 years
Overall survival at 2 and 5 years
Overall survival
Measured: 2-5 years
Colon cancer specific death at 2 and 5 years
Colon cancer specific death
Measured: 2-5 years
Artesunate drug related toxicity
drug related toxicity
Measured: 5 years
Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)
Pathological assessment
Measured: 5years
Surgical morbidity/mortality
Surgical morbidity/mortality
Measured: 5years
Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy
tumour biomarkers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start8 Jan 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 108 Military Central Hospital
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen
- Responsible party
- Principal investigator, Le Huu Song, The 108 Military Central Hospital
- Investigators
- Mai Hong Bang, MD,PhD, Study director, 108 Military Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093129
- Sponsor's protocol ID
- NeoArt-V
- Acronym
- NeoART-V
- Status last verified
- Jan 2018
- First submitted
- 16 Mar 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krishna S, Ganapathi S, Ster IC, Saeed ME, Cowan M, Finlayson C, Kovacsevics H, Jansen H, Kremsner PG, Efferth T, Kumar D. A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer. EBioMedicine. 2014 Nov 15;2(1):82-90. doi: 10.1016/j.ebiom.2014.11.010. eCollection 2015 Jan.
PubMed 26137537
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. 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 in Vietnamese Patients
- ClinicalTrials.gov ID
- NCT03093129
- Acronym / sponsor ID
- NeoART-V / NeoArt-V
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The 108 Military Central HospitalOther government
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Mar 2017 (actual)
- 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 is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide and represents a significant health care burden with an incidence of one million new cases per year. In Vietnam, Colorectal cancer is the third most common cause of cancer deaths in men and fourth in women. Artesunate is a safe and effective antimalarial with evidence of anticancer properties across a range of cancer cell lines. Results from a pilot feasibility study in colorectal cancer patients in the UK showed that artesunate was safe and well tolerated. These findings provided the basis for a Phase II clinical trial investigating the effects of neoadjuvant artesunate on progression free survival and overall survival in Stage II/III Colorectal Cancer in Vietnamese Patients.
Artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artesunate | Active comparator | Drug: artesunatePatients will receive 200 mg artesunate (Arinate®) per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery. |
| placebo | Placebo comparator | Other: placeboPatients will receive matching placebo tablets per oral (PO) once daily (OD) for fourteen days prior to their planned surgery and then be followed up for 5 years following surgery. |
Who may qualify
- Ages
- 18 to 70 years
- 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
- 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 109 /l; Platelets >100 x 109/l; Haemoglobin (Hb) >8g/dL
Key exclusion criteria (8 listed)
- Contraindication to the use of artesunate due to hypersensitivity
- Pregnancy or lactation
- History of immunosuppression
- History of hearing or balance problems
- Weight < 42 kg or > 110 kg
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 |
|---|---|---|
| artesunateAlso: Arinate®Artesunate (Trade name : Arinate®) Artemisinins are a family of sesquiterpene trioxane anti-malarial agents derived from Sweet wormwood (Artemisia annua L) that have been used in traditional Chinese medicine for centuries to treat fevers. Artesunate, artemether and arteether are derivatives of artemisinin that are converted into their active metabolite dihydroartemisinin (DHA). Artesunate is approved for the treatment of uncomplicated and multidrug-resistant malaria and is on the WHO list of Essential Medicines (WHO., 2015). | Drug | artesunate |
| placeboThe matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend. | Other | placebo |
Primary outcome
recurrence free survival 2 years after surgery
Time frame: 2 years
The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery
7 secondary outcomes
Recurrence free survival at 5 years
Time frame: 5 years
Overall survival at 2 and 5 years
Time frame: 2-5 years
Colon cancer specific death at 2 and 5 years
Time frame: 2-5 years
Artesunate drug related toxicity
Time frame: 5 years
Pathological assessment of tumour regression (involvement of lymph nodes ; serosa ; resection margin)
Time frame: 5years
Surgical morbidity/mortality
Time frame: 5years
Predictive value of tumour biomarkers in terms of predicting response to artesunate therapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 26137537Krishna S, Ganapathi S, Ster IC, Saeed ME, Cowan M, Finlayson C, Kovacsevics H, Jansen H, Kremsner PG, Efferth T, Kumar D. A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer. EBioMedicine. 2014 Nov 15;2(1):82-90. doi: 10.1016/j.ebiom.2014.11.010. eCollection 2015 Jan.
- Individual participant dataSharing planned: Undecided
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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.
Mai Hong Bang, MD,PhD study director
108 Military Central Hospital
1 site 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 in people with Colorectal Cancer, run by The 108 Military Central Hospital at 1 site in Vietnam.
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 8 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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 Le Huu Song, MD, PhD (+84-974845270, lehuusong@108-icid.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence free survival 2 years after surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093129, which also lists 1 linked publication.
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 9 Jan 2018.