EMT2: EPA for Metastasis Trial

Phase 1

• Conditions: Colorectal cancer liver metastases; MedDRA version: 20.0Level: LLTClassification code 10007095Term: Cancer of liver, secondarySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000628-24-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-08
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 448

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 metastasis with curative intent, including repeat ‘re-do’ colorectal cancer liver metastasis liver surgery (a second independent resection for a separate colorectal cancer liver recurrence)
•Intention to receive =2 weeks treatment with IMP prior to colorectal cancer liver metastasis surgery

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Incurable extra-hepatic metastases
•Current (in the last 2 months) or planned regular (>3 doses per week) use of O3FA-containing supplements, including fish oil and cod-liver oil supplements
•Fish/seafood allergy
•<2 weeks before planned CRCLM surgery
•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 bilateral orchidectomy) and not willing to use effective contraceptive measures if appropriate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified