Condition category
Cancer
Date applied
04/06/2003
Date assigned
23/07/2003
Last edited
26/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

http://www.ucl.ac.uk/cancertrials/trials/clocc/index.htm

Contact information

Type

Scientific

Primary contact

Dr Wendy Wood

ORCID ID

Contact details

CR UK and UCL Cancer Trials Centre
90 Tottenham Court Road
London
London
W1T 4TJ
United Kingdom
+44 (0)20 7679 9858
W.Wood@CTC.UCL.AC.UK

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00043004

Protocol/serial number

EORTC 40004

Study information

Scientific title

Acronym

CLOCC

Study hypothesis

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

LREC approval for UK sites

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

5-Fluorouracil (5FU), LeucoVorin (LV) and oxaliplatin.

Primary outcome measures

To determine whether radiofrequency in combination with chemotherapy leads to superior overall survival compared to chemotherapy alone.

Secondary outcome measures

1. Progression free survival
2. Quality of Life
3. Health economics

Overall trial start date

01/04/2003

Overall trial end date

30/09/2007

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

142

Participant 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

Recruitment start date

01/04/2003

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CR UK and UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

Cancer Research UK

Sponsor details

PO Box 123
61 Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)20 7317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (ref: C8374/A3488)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=49261

Publication citations

Additional files

Editorial Notes