Table 1.
FOXFIRE Inclusion/Exclusion criteria
| Inclusion criteria | Exclusion criteria |
|---|---|
| 1. Histologically confirmed colorectal cancer (CRC) with liver-only or liver-dominant metastases not amenable to curative surgical resection confirmed at a Multi-disciplinary team (MDT) meeting |
1. Liver metastases amenable to curative resection, unless limited EHD |
| 2. Unequivocal & measurable CT evidence of liver metastases, not treatable by surgical resection or local ablation with curative intent at time of trial entry |
2. Pregnant or breast-feeding |
| 3. Age ≥ 18 years |
3. Evidence of ascites, cirrhosis or portal hypertension |
| 4. WHO performance status of 0–1 |
4. Main portal venous tumour involvement or thrombosis |
| 5. Life expectancy > 3 months |
5. Previous radiotherapy to upper abdomen or upper lumbar spine |
| 6. Adequate haematological, renal and hepatic function |
6. Other active malignancy within last 5 years [excluding colorectal cancer and other non-melanoma skin cancers] |
| 7. Eligible for systemic chemotherapy as 1st line treatment for metastatic CRC |
7. Non-malignant disease that would render patient ineligible at the discretion of the Investigator |
| 8. Liver only/limited extra-hepatic disease (EHD): metastases in the lung must not be more than 5 in number and should be, in the opinion of either the local multi-disciplinary team (MDT) or following central review of scans arranged via the Trials Office, amenable to future definitive local therapy. In addition to lung metastases, a single site of other extra-hepatic disease is permitted (e.g. multiple lymph nodes in one lymph node region) after approval by the Trials Office. |
8. Equivocal, immeasurable, or unevaluable liver metastases |
| 9. Patients are permitted to have a primary colorectal tumour in situ, which should be potentially resectable following protocol therapy |
9. Unequivocal evidence of bone metastasis |
| 10. Suitable for all aspects of treatment determined by clinical assessment undertaken by Investigator |
10. DLT associated with previous 5-FU or oxaliplatin chemotherapy |
| 11. Using adequate contraception if pre-menopausal (male and female patients) |
11. Previous chemotherapy for metastatic colorectal cancer [last dose of adjuvant chemotherapy for CRC administered ≥ 6 months pre-randomisation] |
| 12. Willing & able to provide written informed consent | 12. Peripheral neuropathy > CTCAE Grade 1 |