FOXFIRE

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.

STUDY STATUS

Open to recruitment.
Target recruitment: 490 patients
Current recruitment: 124 patients (Juy 2012)
Number of active sites: 29 (July 2012)

Open Sites:

• 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.

STUDY SCHEMA

INCLUSION CRITERIA

• 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.

EXCLUSION CRITERIA

• 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.

PRIMARY OBJECTIVES

• Overall survival

General Enquiries: Tel: +44 (0)1865 617 012, Fax: +44 (0)1865 617 010