MedTrace Logo

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

NCT02633098 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-10-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artesunate 200mg

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

DRUG

Placebo

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

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Professor Sanjeev Krishna, BMBCh, DPhil, ScD · St George's University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2022-12-31
Completion
2025-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633098 on ClinicalTrials.gov