Colon Cancer Clinical Trial
— EMT2Official title:
A Randomised Placebo-controlled Phase III Trial of the Effect of the Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA) on Colorectal Cancer Recurrence and Survival After Surgery for Resectable Liver Metastases
Verified date | December 2023 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)
Status | Active, not recruiting |
Enrollment | 418 |
Est. completion date | April 30, 2026 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged = 18 years - Able to provide written informed consent - Histological diagnosis of colorectal cancer with evidence of liver metastases - Planned liver resection surgery for colorectal cancer liver metastases with curative intent, including repeat 're-do' colorectal cancer liver metastases surgery (a second independent resection for a separate colorectal cancer liver recurrence) - Intention to receive IMP prior to colorectal cancer liver metastases surgery Exclusion Criteria: - Previous CRCLM surgery for the management of the current metastatic disease - Incurable extra-hepatic metastases - Current (in the last 2 months) or planned regular (>3 doses per week) use of O3FA-containing drugs or supplements, including Vazkepa®, Omacor®, fish oil and cod-liver oil supplements - Fish/seafood allergy - Diagnosis of hereditary fructose intolerance - Soya or peanut allergy - Inability to comply with trial treatment and follow-up schedule - Known bleeding tendency/condition (e.g. von Willebrand disease) - A previous malignancy within the last 5 years other than: - colorectal cancer - non-melanoma skin cancer where treatment consisted of resection only or radiotherapy - ductal carcinoma in situ (DCIS) where treatment consisted of resection only - cervical carcinoma in situ where treatment consisted of resection only - superficial bladder carcinoma where treatment consisted of resection only - A previous malignancy where the patient has been disease free for = 5 years - Pregnant or breastfeeding women or women of childbearing potential not willing to use effective contraceptive measures. Women of childbearing potential are defined as fertile, following menarche and until becoming post-menopausal, unless permanently sterile - Men defined as fertile (post-pubescent and not permanently sterile by vasectomy or bilateral orchidectomy) and not willing to use effective contraceptive measures if appropriate. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aintree University Hospitals NHS Foundation Trust | Aintree | |
United Kingdom | Hampshire Hospitals NHS Foundation Trust | Basingstoke | Royal Hampshire |
United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
United Kingdom | Cambridge UniversityHospitals NHS Foundation Trust | Cambridge | |
United Kingdom | University Hospital of Wales | Cardiff | |
United Kingdom | Leeds Teaching Hospitals NHS Foundation Trust | Leeds | |
United Kingdom | King's College London | London | |
United Kingdom | Royal Free London NHS Foundation Trust | London | |
United Kingdom | Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
United Kingdom | Oxford University Hospital NHS Foundation Trust | Oxford | Oxfordshire |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
Mark A Hull, PhD FRCP | Amarin Pharma Inc., Yorkshire Cancer Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Red Blood Cell Membrane EPA content (exploratory endpoint) | EPA content measured at baseline, surgery and 6 months after surgery. Samples taken at selected sites only | Samples taken at baseline, surgery and 6 months after surgery | |
Other | Change in lean body mass (exploratory endpoint) | Change in lean body mass measured by CT scanning during follow-up as assessed by the L3 skeletal muscle index score. Scans reviewed from selected sites only | 6 months and up to 4 years follow up | |
Primary | Progression Free Survival (PFS) | PFS is defined as the time from randomisation to death (from any cause), first documented evidence of disease progression, new recurrence or clinical deterioration unequivocally due to disease progression | Minimum of 2 years follow-up | |
Secondary | Overall Survival (OS) | The time from randomisation to death, from any cause (key secondary endpoint) | Minimum of 2 years follow-up | |
Secondary | Safety and Tolerability of Icosapent Ethyl | The number of participants with treatment-emergent adverse events as defined by CTCAE v4.0 | Minimum of 2 years follow-up | |
Secondary | Patient reported quality of life 1 | Measured using the EQ-5D questionnaire | Minimum of 2 years follow-up | |
Secondary | Patient reported quality of life 2 | Measured using the EORTC QLQ-C30 questionnaire | Minimum of 2 years follow-up | |
Secondary | Patient reported quality of life 3 | Measured using the QLQ-LMC21 questionnaire | Minimum of 2 years follow-up | |
Secondary | New Primary Cancers | Excluding DCIS, cervical carcinoma in situ, superficial bladder carcinoma where treatment consisted of resection only and non-melanoma skin cancer where treatment consisted of resection or radiotherapy only) | Minimum of 2 years follow-up |
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