Title

FOXFIRE

Chief Investigator: 
Ricky Sharma and Harpreet Wasan

Sponsor: University of Oxford
Funded by: Cancer Research UK

FOXFIRE UPDATE

Follow up of FOXFIRE patients and final database lock are now complete. Thank you to all sites for their support in reaching these milestones. 2017 will be an exciting year as the results of the study are analysed, presented and published.

Please follow this link to the FOXFIRE ASCO Abstract : http://abstracts.asco.org/199/AbstView_199_184921.html

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.

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.
 

Study Status

Closed to recruitment

Target recruitment: 356 patients
Final recruitment:  364 patients (Oct 2014)
Number of sites that recruited:  26 (Oct 2014)

Sites:

  • Addenbrookes Hospital, Cambridge
  • Belfast City Hospital
  • Bristol Haematology & Oncology Centre
  • Christie Hospital, Manchester
  • Churchill Hospital, Oxford
  • Great Western Hospital, Swindon
  • Guys Hospital (Kings Health Partnership), London
  • Ipswich Hospital
  • Imperial College Healthcare NHS Trust (Charing Cross & Hammersmith Hospitals), 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
  • 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

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
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