EPA for Metastasis Trial 2

NCT03428477 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MO16/053
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 13

Brief Summary

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)

Conditions

Liver Metastasis; Colon Cancer

Keywords

Liver metastases; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  Minimum of 2 years follow-up

• Safety and Tolerability of Icosapent Ethyl

  Minimum of 2 years follow-up

• Patient reported quality of life 1

  Minimum of 2 years follow-up

• Patient reported quality of life 2

  Minimum of 2 years follow-up

• Patient reported quality of life 3

  Minimum of 2 years follow-up

Other Outcomes (2)

• Red Blood Cell Membrane EPA content (exploratory endpoint)

  Samples taken at baseline, surgery and 6 months after surgery

• Change in lean body mass (exploratory endpoint)

  6 months and up to 4 years follow up

Study Arms (2)

Icosapent Ethyl (EPA-EE)

EXPERIMENTAL

Soft gelatin capsules containing 1g pure EPA-EE equivalent to 914mg EPA-FFA. Administered as 4g per day to be taken as 2 capsules in the morning and 2 capsules in the evening.

Drug: Icosapent Ethyl

Placebo

PLACEBO COMPARATOR

Soft gelatin capsules containing light mineral oil. 4 capsules to be taken per day (2 in the morning and 2 in the evening).

Other: Placebo

Interventions

Icosapent Ethyl DRUG

Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day

Also known as: Vascepa

Icosapent Ethyl (EPA-EE)

Placebo OTHER

Composition: soft, amber to light yellow, oblong gelatin capsules containing light mineral oil: Dose: 4 capsules per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark A Hull, PhD FRCP: lead
• Yorkshire Cancer Research: collaborator
• Amarin Pharma Inc.: collaborator

Study Sites (13)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Royal Hampshire, RG24 9NA, United Kingdom

Location

Aintree University Hospitals NHS Foundation Trust

Aintree, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Cambridge UniversityHospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Leeds Teaching Hospitals NHS Foundation Trust

Leeds, United Kingdom

Location

King's College London

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

Related Publications (1)

• Hull MA, Ow PL, Ruddock S, Brend T, Smith AF, Marshall H, Song M, Chan AT, Garrett WS, Yilmaz O, Drew DA, Collinson F, Cockbain AJ, Jones R, Loadman PM, Hall PS, Moriarty C, Cairns DA, Toogood GJ. Randomised, placebo-controlled, phase 3 trial of the effect of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases: EPA for Metastasis Trial 2 (EMT2) study protocol. BMJ Open. 2023 Nov 29;13(11):e077427. doi: 10.1136/bmjopen-2023-077427.

  PMID: 38030258 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mark Hull

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Mark Hull

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 9, 2018
• Study Start: May 2, 2018
• Primary Completion: November 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on, for as long as CTRU retains the data.
• Access Criteria: Data will be released for secondary research purposes, where the Chief Investigator, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (scientific rigour and information governance and security), and that suitable resources are available. Data will be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No IPD will be released before an appropriate agreement is in place governing data retention, usually stipulating that data recipients must delete their copy of the data at the end of the project. The CTRU believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, key trial documents and any other information required to reuse the datasets.

Locations

GB (13)