FOXFIRE continues to recruit well across the whole of the UK, averaging 9 patients per month. We have recruited 298 patients so far and we are on course to meet our revised target recruitment this year.
Although FOXFIRE in the UK is on target and recruiting very well, “FOXFIRE-Global” outside the UK is not recruiting to target. The other study outside the UK is required for FOXFIRE to achieve its overall survival statistic. Consequently, we have calculated that FOXFIRE will have to stay open for an additional 4 months for us to reach the overall recruitment target of 1022 patients internationally.
You may remember that FOXFIRE was developed by the NCRI Colorectal Clinical Study Group (CSG). The CTAAC funding body of Cancer Research UK, the NCRI Colorectal CSG, and the Trial Management Group of FOCUS4, the only competing study, are fully supportive of this extension of recruitment to FOXFIRE. The Trial Management Groups from FOCUS4 and FOXFIRE have made a clear statement about our strategy for recruiting patients to centres participating in both studies, a strategy that will remain valid until the end of October 2014. If a patient is eligible for both studies, please offer them FOXFIRE in preference to FOCUS4, as agreed by the FOCUS4 investigators.
We can therefore confirm to you now that recruitment in FOXFIRE will continue until 31 October 2014 (rather than 30 June 2014 as you previously thought) and that we will continue patient follow-up until 31 October 2016, with the final data lock 6-9 months from the end of follow-up
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: 356 patients
Current recruitment: 338 patients (Jun 2014)
Number of active sites: 32 (Jun 2014)
- Addenbrookes Hospital, Cambridge
- Belfast City Hospital
- Bristol Haematology & Oncology Centre
- Charing Cross, London
- Christie Hospital, Manchester
- Churchill Hospital, Oxford
- The Freeman Hospital, Newcastle
- Great Western Hospital, Swindon
- Guys Hospital (Kings Health Partnership), London
- Hammersmith Hospital, London
- Huddersfield Royal Infirmary
- Ipswich Hospital
- King’s Hospital (Kings Health Partnership), London
- Lister Hospital
- Nottingham City Hospital
- Queen Elizabeth hospital, Birmingham
- Royal Bournemouth
- Royal Free Hospital, London
- Royal Liverpool University Hospital
- Royal Marsden Hospital (Sutton and London)
- Royal Surrey County Hospital, Guildford
- 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
- Weston Park, Sheffield
- Wexham Park
- Wycombe Hospital
A similar multi-centre randomised controlled trial called SIRFLOX finished recruiting at the end of March 2013 with a total of 525 patients. FOXFIRE-Global, a SIRFLOX extension, study is now recruiting.
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