{"registry": "ISRCTN", "registryId": "ISRCTN22944367", "source": "https://www.isrctn.com/ISRCTN22944367", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN22944367/format/default", "fetchedAt": "2026-10-07T17:01:20.646824Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"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", "scientificTitle": "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", "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.\n\nOn 04/05/2007 the target number of participants was changed from 330 to 340.\n\nOn 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.\n\nOn 30/10/2013 the following changes were made to the trial record:\n1. 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.\n2. The target number of participants was changed from 340 to 288.\nDetails of other changes can be found in the relevant fields.", "primaryOutcome": "Progression-free survival", "secondaryOutcome": "Current secondary outcome measures as of 30/10/2013:\n1. Toxicity\n2. Overall survival \n\nPrevious secondary outcome measures:\n1. Quality of life\n2. Toxicity\n3. Overall survival\n4. Cost effectiveness", "intervention": "\n\tExperimental arm: \nOxaliplatin/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.\n\nControl arm: \nOxaliplatin/fluoropyrimidine for three months. Surgical resection when fit following chemotherapy. Three additional months of chemotherapy when fit following surgery.\n\nAs of 04/05/2007 the anticipated start and end dates have been updated to:\nAnticipated start date: the study opened to recruitment on 5th February 2007\nAnticipated end date: December 2014\n\nThe previous sponsor for this trial (up to 04/05/2007) was:\nUniversity of Southampton (UK) \nResearch Governance Office \nLegal Services \nRoom 4033, Building 37 \nUniversity Road \nSouthampton \nSO17 1BJ \nUnited Kingdom \n\nBetween 04/05/2007 and 08/08/2008, the sponsor address was:\nSouthampton University Hospitals NHS Trust (UK)  \nResearch and Development \nTrust Management Offices, MP18 \nSouthampton General Hospital  \nSouthampton\nSO16 6YD  \nUnited Kingdom  \nThe current address can be found in the sponsor section below.\n\tDrug\n\tPhase III\n\tOxaliplatin, fluoropyrimidine, cetuximab\n      ", "condition": "\n\tColorectal cancer with liver metastases\n\tCancer\n\tColorectal cancer\n      ", "studyDesign": "An open label randomized controlled trial", "overallEndDate": "2018-05-01T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00482222", "lastUpdated": "2023-07-21T13:14:42.111066Z", "eligibility": {"inclusion": "Current inclusion criteria as of 08/08/2008:\n1. 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\n2. Presence of potentially resectable colorectal cancer liver metastases\n3. Patients who are thought by the surgeon to be suboptimally resectable are included\n4. No  previous systemic chemotherapy for metastatic disease\n5. World Health Organization (WHO) performance status 0, 1 or 2\n\nAdded as of 04/05/2007:\n6. Baseline laboratory tests (refer to the protocol for full description) \n7. All patients must be aged 18 years or older\n8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women\n9. Written informed consent\n10. 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)\n\nPrevious inclusion criteria:\n1. 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\n2. Presence of potential colorectal cancer resectable liver metastases\n3. Patients who are thought by the surgeon to be suboptimally resectable are included\n4. No  previous systemic chemotherapy for metastatic disease\n5. World Health Organization (WHO) performance status 0, 1 or 2\n\nAdded as of 04/05/2007:\n6. Baseline laboratory tests (refer to the protocol for full description) \n7. All patients must be aged 18 years or older\n8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women\n9. Written informed consent\n10. 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)", "exclusion": "Patients who are unfit for the chemotherapy regimens in the protocol e.g.:\n1. Patients with severe uncontrolled concurrent medical illness\n2. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or comply with oral medication\n3. Partial or complete bowel obstruction\n4. Pre-existing neuropathy (> grade 1)\n5. Patients requiring ongoing treatment with a contraindicated concomitant medication\n6. 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\n\nAdded as of 04/05/2007:\n7. Patients with known hypersensitivity reactions to any of the components of the study treatments\n8. Patients with brain metastases\n9. Female patients who are lactating\n\nAdded as of 08/08/2008:\n10. Patients who have received prior chemotherapy with oxaliplatin\n11. Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency\n12. Patients who possess the KRAS mutant genotype or whose KRAS genotype status is unknown in the primary tumour", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2006-08-01T00:00:00.000Z", "recruitmentEnd": "2018-05-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "288", "totalFinalEnrolment": "257"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "University Surgical Unit MP816", "city": "Southampton", "state": "", "country": "United Kingdom", "zip": "SO16 6YD"}], "sponsors": [{"organisation": "University Hospital Southampton NHS Foundation Trust (UK)", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/0485axj58"}], "funders": [{"name": "Cancer Research UK (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "5e08c3a82e8c55580b2c846b0f6c5d63c108fd87d05f48b32a9b2e9898e6cb64"}