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
| ISRCTN | ISRCTN58458258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58458258 |
| ClinicalTrials.gov (NCT) | NCT00043004 |
| Protocol serial number | EORTC 40004 |
| Sponsor | Cancer Research UK |
| Funder | Cancer Research UK (ref: C8374/A3488) |
- Submission date
- 04/06/2003
- Registration date
- 23/07/2003
- Last edited
- 23/04/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wendy Wood
Scientific
Scientific
CR UK and UCL Cancer Trials Centre
90 Tottenham Court Road
London
London
W1T 4TJ
United Kingdom
| Phone | +44 (0)20 7679 9858 |
|---|---|
| W.Wood@CTC.UCL.AC.UK |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | CLOCC |
| Study objectives | The liver is the common site of relapse in patients with colorectal cancer. Chemotherapy is the treatment of choice for patients where surgical removal of lesions is not possible. The outcome for patients with unresectable liver metastases treated with chemotherapy is poor; five year survival of less than 1% and median survival less than one year. Tumour destruction using radio frequency may offer an improvement in outcome. The purpose of this trial is to treat patients who have inoperable metastases with chemotherapy or RadioFrequency Ablation (RFA) and chemotherapy. The chemotherapy schedule used will be a combination of 5-Fluorouracil (5FU), leucovorin and oxaliplatin. |
| Ethics approval(s) | LREC approval for UK sites |
| Health condition(s) or problem(s) studied | Liver metastases in colorectal cancer |
| Intervention | Arm one: Radiofrequency ablation and chemotherapy Arm two: Chemotherapy alone. Radiofrequency: 1. Tumour ablative technique which can be combined with surgery 2. Imaging of procedure by ultrasound 3. During radiofrequency thermal heat injury leads to tissue coagulation 4. Effective in the local destruction of liver metastases 5. Suitable for lesions which are not totally resectable due to number or location and close to large blood vessels Chemotherapy: 1. Oxaliplatin 85mg/m^2 day one only 2. Leucovorin 175mg/m^2 day one only 3. 5-Fluorouracil 400mg/m^2 bolus 4. 5FU 2400mg/m^2 at 46 hours intravenous infusion 5. Fortnightly for six months i.e. 12 courses |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil (5FU), LeucoVorin (LV) and oxaliplatin. |
| Primary outcome measure(s) |
To determine whether radiofrequency in combination with chemotherapy leads to superior overall survival compared to chemotherapy alone. |
| Key secondary outcome measure(s) |
1. Progression free survival |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 142 |
| Total final enrolment | 119 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CR UK and UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom
W1T 4TJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2012 | 23/04/2021 | Yes | No | |
| Abstract results | No | No | |||
| Abstract results | 20/05/2008 | 23/04/2021 | No | No | |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
