FOXFIRE

STUDY STATUS

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 0-2.
• 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

Oncology Clinical Trials Office (OCTO)