Contact information
Type
Scientific
Primary contact
Prof John Primrose
ORCID ID
Contact details
University Surgical Unit MP816
F Level Centre Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 6144
j.n.primrose@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00482222
Protocol/serial number
UOS ref: 4351
Study information
Scientific title
A prospective randomised open label trial of oxaliplatin/fluoropyrimidine versus oxaliplatin/fluoropyrimidine plus cetuximab pre- and post-operatively in patients with resectable colorectal liver metastasis requiring chemotherapy
Acronym
New EPOC
Study hypothesis
To determine whether the addition of an epidermal growth factor receptor (EGFR) antibody to an oxaliplatin/fluoropyrimidine regimen improves progression-free survival in patients with resectable liver metastasis from colorectal cancer undergoing liver resection.
On 04/05/2007 the target number of participants was changed from 330 to 340.
On 08/08/2008 the including and exclusion criteria were updated. The sponsor address was also updated. Details of all changes can be found in the relevant fields.
On 30/10/2013 the following changes were made to the trial record:
1. The anticipated end date was changed from 31/08/2011 to 01/05/2018. The trial is now closed to recruitment and patients are in follow-up for 5 years.
2. The target number of participants was changed from 340 to 288.
Details of other changes can be found in the relevant fields.
Ethics approval
This study was given a favourable ethical opinion on 01/12/2006
Study design
An open label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Colorectal cancer with liver metastases
Intervention
Experimental arm:
Oxaliplatin/fluoropyrimidine/anti-EGFR antibody for three months. Surgical resection when fit following chemotherapy, usually 3-4 weeks. Three additional months of chemotherapy when fit following surgery, usually after one month.
Control arm:
Oxaliplatin/fluoropyrimidine for three months. Surgical resection when fit following chemotherapy. Three additional months of chemotherapy when fit following surgery.
As of 04/05/2007 the anticipated start and end dates have been updated to:
Anticipated start date: the study opened to recruitment on 5th February 2007
Anticipated end date: December 2014
The previous sponsor for this trial (up to 04/05/2007) was:
University of Southampton (UK)
Research Governance Office
Legal Services
Room 4033, Building 37
University Road
Southampton
SO17 1BJ
United Kingdom
Between 04/05/2007 and 08/08/2008, the sponsor address was:
Southampton University Hospitals NHS Trust (UK)
Research and Development
Trust Management Offices, MP18
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
The current address can be found in the sponsor section below.
Intervention type
Drug
Phase
Phase III
Drug names
Oxaliplatin, fluoropyrimidine, cetuximab
Primary outcome measure
Progression-free survival
Secondary outcome measures
Current secondary outcome measures as of 30/10/2013:
1. Toxicity
2. Overall survival
Previous secondary outcome measures:
1. Quality of life
2. Toxicity
3. Overall survival
4. Cost effectiveness
Overall trial start date
01/08/2006
Overall trial end date
01/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 08/08/2008:
1. Confirmed colorectal adenocarcinoma: either previous or current histologically or radiologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease; confirmed primary adenocarcinoma of colon or rectum
2. Presence of potentially resectable colorectal cancer liver metastases
3. Patients who are thought by the surgeon to be suboptimally resectable are included
4. No previous systemic chemotherapy for metastatic disease
5. World Health Organization (WHO) performance status 0, 1 or 2
Added as of 04/05/2007:
6. Baseline laboratory tests (refer to the protocol for full description)
7. All patients must be aged 18 years or older
8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women
9. Written informed consent
10. Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary study and still participate in the main trial)
Previous inclusion criteria:
1. Confirmed colorectal adenocarcinoma: either previous or current histologically or radiologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease; confirmed primary adenocarcinoma of colon or rectum
2. Presence of potential colorectal cancer resectable liver metastases
3. Patients who are thought by the surgeon to be suboptimally resectable are included
4. No previous systemic chemotherapy for metastatic disease
5. World Health Organization (WHO) performance status 0, 1 or 2
Added as of 04/05/2007:
6. Baseline laboratory tests (refer to the protocol for full description)
7. All patients must be aged 18 years or older
8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women
9. Written informed consent
10. Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary study and still participate in the main trial)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
288
Participant exclusion criteria
Patients who are unfit for the chemotherapy regimens in the protocol e.g.:
1. Patients with severe uncontrolled concurrent medical illness
2. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or comply with oral medication
3. Partial or complete bowel obstruction
4. Pre-existing neuropathy (> grade 1)
5. Patients requiring ongoing treatment with a contraindicated concomitant medication
6. Patients with a previous or current malignant disease which in the judgement of the treating investigator, is likely to interfere with this study treatment or assessment of response
Added as of 04/05/2007:
7. Patients with known hypersensitivity reactions to any of the components of the study treatments
8. Patients with brain metastases
9. Female patients who are lactating
Added as of 08/08/2008:
10. Patients who have received prior chemotherapy with oxaliplatin
11. Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency
12. Patients who possess the KRAS mutant genotype or whose KRAS genotype status is unknown in the primary tumour
Recruitment start date
01/08/2006
Recruitment end date
01/05/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Surgical Unit MP816
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University Hospital Southampton NHS Foundation Trust (UK)
Sponsor details
R&D Office
MP18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24717919 (added 11/04/2019)
2. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27434036 (added 11/04/2019)
3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29212194 (added 11/04/2019)