A prospective randomised open label trial of oxaliplatin/fluoropyrimidine versus oxaliplatin/fluoropyrimidine plus cetuximab pre- and post-operatively in patients with resectable colorectal liver metastasis requiring chemotherapy
- Conditions
- Colorectal cancer with liver metastasesCancerColorectal cancer
- Registration Number
- ISRCTN22944367
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust (UK)
- Brief Summary
2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24717919 results (added 11/04/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27434036 results (added 11/04/2019) 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29212194 results (added 11/04/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32014119 results (added 06/02/2020) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37471075/ Secondary analysis (added 21/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 257
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method <br> Current secondary outcome measures as of 30/10/2013:<br> 1. Toxicity<br> 2. Overall survival<br><br> Previous secondary outcome measures:<br> 1. Quality of life<br> 2. Toxicity<br> 3. Overall survival<br> 4. Cost effectiveness<br>