An open-label randomised phase III trial of 5-Fluorouracil, OXaliplatin and Folinic acid +/- Interventional Radio-Embolisation as first line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer.
Chief Investigators: Dr Ricky Sharma & Dr Harpreet Wasan
Sponsor: University of Oxford
Funded by: Cancer Research UK
The aim of the trial is to compare chemotherapy alone (5-FU, oxaliplatin & folinic acid) with chemotherapy plus radioembolisation for colorectal cancer that has spread to the liver.
Open to recruitment.
Target recruitment: 490 patients
Current recruitment: 124 patients (Juy 2012)
Number of active sites: 29 (July 2012)
- Addenbrookes Hospital, Cambridge
- Belfast City Hospital
- Bristol Haematology & Oncology Centre
- Charing Cross, London
- Christie Hospital, Manchester
- Churchill Hospital, Oxford
- Great Western Hospital, Swindon
- Guys Hospital (Kings Health Partnership), London
- Hammersmith Hospital, London
- Ipswich Hospital
- King’s Hospital (Kings Health Partnership), London
- Lister Hospital
- Nottingham City Hospital
- Royal Bournemouth
- Royal Free Hospital, London
- Royal Liverpool University Hospital
- Royal Marsden Hospital (Sutton and London)
- Royal Surrey County Hospital, Guildford
- Weston Park, Sheffield
- Stoke Mandeville Hospital
- Southampton General Hospital
- St Georges Hospital, London
- St James's University Hospital, Leeds
- University Hospitals of Leicester NHS Trust
- Velindre Hospital, Cardiff
- Western General Hospital
- Wexham Park
- Wycombe Hospital
A similar multi-centre randomised controlled trial called SIRFLOX is being conducted at sites across Australia, New Zealand, Europe, the Middle East and the USA.
Click here for a link to the SIRFLOX website.
- Histologically confirmed colorectal cancer with liver-dominant metastases not amenable to surgical resection.
- Unequivocal & measurable CT evidence of liver metastases, not treatable by surgical resection or local ablation with curative intent at time of trial entry.
- Age >= 18 years
- WHO performance status of 0-1.
- Life expectancy > 3 months.
- Adequate haematological, renal and hepatic function.
- Low volume extra-hepatic disease (EHD) will be included.
- Willing and able to provide written informed consent.
- Pregnant or breast feeding.
- Evidence of ascites, cirrhosis or portal hypertension.
- Markedly abnormal synthetic or excretory liver function tests.
- Main portal venous tumour involvement or thrombosis.
- Previous radiotherapy to upper abdomen.
- Equivocal, immeasurable, or unevaluable metastases in the liver.
- DLT associated with previous 5-FU or oxaliplatin chemotherapy.
- Previous chemotherapy for any malignancy. [Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that the last dose of adjuvant chemotherapy was administred at least 6 months prior to randomisation].
- Other active malignancy.
Oncology Clinical Trials Office (OCTO)
General Enquiries: Tel: +44 (0)1865 617 012, Fax: +44 (0)1865 617 010
Randomisation Service Mon-Fri 9-5 (UK Time): UK Tel: 0800 389 1635
, UK Fax: 0800 389 1629
(24hrs) Non UK Tel: +44 (0)1865 617 014
, Non UK Fax: +44 (0)1865 617 015