Colorectal cancer liver metastases MedDRA version: 20.0 Level: LLT Classification code 10007095 Term: Cancer of liver, secondary System Organ Class: 100000004864
Conditions
Interventions
Product Name: Icosapent Ethyl
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Icosapent Ethyl
CAS Number: 73310-10-8
Other descriptive name: IPE
Concentration unit: g gram(s)
Concentration typ
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial aims to determine whether oral IPE therapy, started at least 2 weeks before surgery and continued for a minimum of 2 years, improves colorectal cancer recurrence in patients undergoing liver resection surgery for colorectal cancer liver metastases.;Secondary Objective: To determine whether IPE treatment improves survival. To confirm the safety and tolerability of IPE before and after surgery, including during chemotherapy. To determine whether IPE treatment improves quality of life after colorectal cancer liver metastasis surgery, as reported by participants. To determine the cost effectiveness of IPE treatment. To determine whether IPE treatment has an effect on the diagnosis of new cancers. ;Primary end point(s): The primary endpoint is progression free survival (PFS) during a minimum of 2 years follow-up. 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. The date of clinical progression is defined as the date of the CT scan or relevant assessment at which disease progression or new recurrence is identified. This can be clinical progression or, for RECIST evaluable disease, radiological progression by RECIST principles. For participants who have clear clinical symptoms of disease progression without confirmatory imaging, the date of progression is defined as the date of the clinical assessment. ;Timepoint(s) of evaluation of this end point: The primary endpoint is evaluated at every visit from visit 3 onwards. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Overall Survival (OS), defined as the time from randomisation to death, from any cause (key secondary endpoint) • Safety and tolerability of IPE before and after CRCLM surgery, including during chemotherapy • Patient reported quality of life, measured using the EQ-5D, EORTC QLQ-C30 and QLQ-LMC21 questionnaires • Cost-effectiveness of IPE • 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) The exploratory endpoints are: • Red blood cell membrane EPA content, measured at baseline, surgery and 6 months after surgery (only patients from Leeds and Sheffield) • Change in lean body mass measured by CT scanning during follow up as assessed by the L3 skeletal muscle index score ;Timepoint(s) of evaluation of this end point: Overall survival is evaluated at every visit from visit 2 onwards. Safety and tolerability of IPE is evaluated at every visit from visit 2 onwards and at fornightly telephone calls with the research nurse between visit 1 and visit 2 and at the telephone call with the research nurse at 60 days after visit 10/exit visit. Patient reported quality of life is collected at visit 1, visit 3 and all visits thereafter. Health economic data is collected at all visits and information on hospital resource activity will also be collected at fornightly telephone calls with the research nurse between visit 1 and visit 2. Evaluation for new primary cancers will take place at every visit from visit 3 onwards. | — |
Countries
United Kingdom
Contacts
Public ContactUniversity of Leeds
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research
Outcome results
None listed