NCT02633098

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2021

Enrollment Period

5.7 years

First QC Date

November 18, 2015

Last Update Submit

October 11, 2022

Conditions

Colorectal CancerBowel Cancer

Keywords

ArtesunateArtemisininsAntimalarialNeoadjuvantPre-operative

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival at 2 years

    2 years following study randomisation.

Secondary Outcomes (39)

  • Recurrence free survival at 5 years

    5 years from study randomisation

  • Overall survival at 2 and 5 years

    2 and 5 years from study randomisation

  • Colon cancer specific death at 2 and 5 years

    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

    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

    Assessment at Day 14 following start of study intervention (artesunate/matching placebo)

  • +34 more secondary outcomes

Study Arms (2)

Artesunate

EXPERIMENTAL

Artesunate 200mg oral tablets once daily for 14 days.

Drug: Artesunate 200mg

Matching placebo

PLACEBO COMPARATOR

Matching placebo oral tablets once daily for 14 days.

Drug: Placebo

Interventions

Artesunate 200mgDRUG

Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery

Artesunate
PlaceboDRUG

Matched placebo PO OD for 14 days prior to colorectal resection surgery

Matching placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

COMPLETED

Kent Oncology Centre, Maidstone Hospital

Maidstone, Kent, ME16 9QQ, 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, DE22 3NE, United Kingdom

RECRUITING

St George's University Hospitals NHS Fundation Trust

London, SW17 0RE, United Kingdom

ACTIVE NOT RECRUITING

Norfolk & Norwich University Hospitlas NHS FT

Norwich, NR4 7UY, United Kingdom

RECRUITING

Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsIntestinal Neoplasms

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Professor Sanjeev Krishna, BMBCh, DPhil, ScD

    St George's University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Sanjeev Krishna, FRCP, ScD, FMedSci

CONTACT

++44(0)208 725 5836s.krishna@sgul.ac.uk

Dr Yolanda Augustin, MBBS, MRCP, FRCR, MSc

CONTACT

++44(0)2087255722yaugusti@sgul.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 17, 2015

Study Start

April 26, 2017

Primary Completion

December 31, 2022

Study Completion

October 31, 2025

Last Updated

October 12, 2022

Record last verified: 2021-10

Locations

GB(8)