Randomised phase III study of the local treatment of liver metastases by radiofrequency combined with chemotherapy versus chemotherapy alone in patients with unresectable colorectal liver metastases
- Conditions
- iver metastases in colorectal cancerCancerMalignant neoplasm of colon
- Registration Number
- ISRCTN58458258
- Lead Sponsor
- Cancer Research UK
- Brief Summary
2008 results presented at ASCO in https://ascopubs.org/doi/abs/10.1200/jco.2008.26.15_suppl.4012 (added 23/04/2021) 2010 results presented at ASCO in http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=49261 2012 results in https://pubmed.ncbi.nlm.nih.gov/22431703/ (added 23/04/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 119
Patients with unresectable colorectal liver metastases:
1. Resection of primary tumour
2. Unresectable liver metastases
3. No extrahepatic disease
4. Total number of metastatic deposits less than ten
5. Maximum diameter of lesions 4cm
6. Patient consent
7. Aged 18 to 80 years
8. Normal haematology and biochemistry
1. World Health Organisation (WHO) status of more than or equal to one
2. Hepatic sufficiency (Bilirubin, Alkaline Phosphatase more than three times the Upper Limit of Normal [ULN])
3. Peripheral neuropathy Common Toxicity Criteria (CTC) grade more than or equal to one
4. Uncontrolled congestive heart failure, angina pectoris, hypertension or arrythmia
5. Any contraindication to the use of 5FU/LV/Oxaliplatin
6. Active infection
7. Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether radiofrequency in combination with chemotherapy leads to superior overall survival compared to chemotherapy alone.
- Secondary Outcome Measures
Name Time Method <br> 1. Progression free survival<br> 2. Quality of Life<br> 3. Health economics<br>