Condition category
Cancer
Date applied
07/06/2006
Date assigned
21/07/2006
Last edited
30/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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 measures

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

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

http://www.suht.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes