E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colorectal cancer liver metastases |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027483 |
E.1.2 | Term | Metastatic neoplasm of liver |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study aims to show the first evidence of anti-cancer properties of EPA in human colorectal cancer liver metastases (CRCLM). In particular we want to see if treatment with EPA daily is associated with a lower ‘proliferation index’ (the amount of tumour cell growth) in CRCLM compared with placebo.
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E.2.2 | Secondary objectives of the trial |
We want to see if treatment with EPA daily:
• is associated with a higher ‘apoptosis index’ (the amount of programmed tumour cell death) and a lower microvessel density (fewer blood vessels supplying the tumour)in colorectal cancer liver metastases (CRCLM) compared with placebo
•leads to incorporation of EPA into CRCLM cell membrane
•leads to an alteration in prostaglandin levels (inflammatory mediators that are implicated in cancer growth) in both cancer tissue and plasma.
•is safe and well tolerated in patients with CRCLM.
There is also some evidence that EPA may exert some anti-proliferative effect by an alternative mechanism (via resolvins) in the presence of aspirin. In our patients who are already taking aspirin, we want to see whether there is any additional effect. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >18 years Either sex Presence of colorectal cancer liver metastasis(es) deemed appropriate for liver resection Duration between decision to perform liver resection and surgery >2 weeks Ability to give written informed consent and follow study protocol Telephone contact possible |
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E.4 | Principal exclusion criteria |
Neo-adjuvant chemotherapy for CRC liver metastasis Chemotherapy for any cancer in the previous 3 months Known bleeding diathesis or anticoagulation therapy Fish or seafood allergy Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study Pregnancy Corticosteroid or non-steroidal anti-inflammatory (NSAID) use (except low dose aspirin) Renal impairment (serum creatanine >150micromol/l) Active inflammatory disease (e.g. Inflammatory Bowel Disease, Rheumatoid Arthritis)
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E.5 End points |
E.5.1 | Primary end point(s) |
Metastasis cancer cell proliferation index (% of cells staining positive for Ki-67 with MIB-1 antibody) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Subject participation in the trial will end after the first postoperative outpatient clinic appointment of the last patient undergoing surgery in the trial (approx 6 weeks after hospital discharge). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |