Status:
ACTIVE_NOT_RECRUITING
EPA for Metastasis Trial 2
Lead Sponsor:
Mark A Hull, PhD FRCP
Collaborating Sponsors:
Yorkshire Cancer Research
Amarin Pharma Inc.
Conditions:
Liver Metastasis
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 st...
Detailed Description
Despite significant advances in diagnosis and treatment of colorectal cancer (CRC), it remains the second most common cause of cancer-related death in the UK. The majority of deaths from CRC are relat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT03428477
Start Date
May 2 2018
End Date
April 30 2026
Last Update
April 18 2025
Active Locations (13)
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1
Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
2
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Royal Hampshire, United Kingdom, RG24 9NA
3
Aintree University Hospitals NHS Foundation Trust
Aintree, United Kingdom
4
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom