Colorectal cancer with liver metastases Cancer Colorectal cancer
Conditions
Interventions
Experimental arm:
Oxaliplatin/fluoropyrimidine/anti-EGFR antibody for three months. Surgical resection when fit following chemotherapy, usually 3-4 weeks. Three additional months of ch
Sponsors
University Hospital Southampton NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/08/2008: 1. Confirmed colorectal adenocarcinoma: either previous or current histologically or radiologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease; confirmed primary adenocarcinoma of colon or rectum 2. Presence of potentially resectable colorectal cancer liver metastases 3. Patients who are thought by the surgeon to be suboptimally resectable are included 4. No previous systemic chemotherapy for metastatic disease 5. World Health Organization (WHO) performance status 0, 1 or 2 Added as of 04/05/2007: 6. Baseline laboratory tests (refer to the protocol for full description) 7. All patients must be aged 18 years or older 8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women 9. Written informed consent 10. Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary study and still participate in the main trial) Previous inclusion criteria: 1. Confirmed colorectal adenocarcinoma: either previous or current histologically or radiologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease; confirmed primary adenocarcinoma of colon or rectum 2. Presence of potential colorectal cancer resectable liver metastases 3. Patients who are thought by the surgeon to be suboptimally resectable are included 4. No previous systemic chemotherapy for metastatic disease 5. World Health Organization (WHO) performance status 0, 1 or 2 Added as of 04/05/2007: 6. Baseline laboratory tests (refer to the protocol for full description) 7. All patients must be aged 18 years or older 8. Negative pregnancy test for women of childbearing potential, adequate contraception for men and women 9. Written informed consent 10. Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary study and still participate in the main trial)
Exclusion criteria
Exclusion criteria: Patients who are unfit for the chemotherapy regimens in the protocol e.g.: 1. Patients with severe uncontrolled concurrent medical illness 2. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or comply with oral medication 3. Partial or complete bowel obstruction 4. Pre-existing neuropathy (> grade 1) 5. Patients requiring ongoing treatment with a contraindicated concomitant medication 6. Patients with a previous or current malignant disease which in the judgement of the treating investigator, is likely to interfere with this study treatment or assessment of response Added as of 04/05/2007: 7. Patients with known hypersensitivity reactions to any of the components of the study treatments 8. Patients with brain metastases 9. Female patients who are lactating Added as of 08/08/2008: 10. Patients who have received prior chemotherapy with oxaliplatin 11. Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency 12. Patients who possess the KRAS mutant genotype or whose KRAS genotype status is unknown in the primary tumour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/10/2013: 1. Toxicity 2. Overall survival Previous secondary outcome measures: 1. Quality of life 2. Toxicity 3. Overall survival 4. Cost effectiveness | — |
Countries
England, United Kingdom
Outcome results
None listed