Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRC COX2
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
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
Colorectal cancer, liver metastases
Intervention
1. Rofecoxib 25 mg/day
2. Placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
05/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age greater than or equal to 18 years
2. Either sex
3. Liver resection deemed clinically appropriate for management of metastatic Colorectal Cancer (CRC) liver disease
4. Duration between decision to perform liver resection and surgery greater than 2 weeks
5. Ability to give written informed consent
6. Telephone at home
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1998
Recruitment end date
05/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Industry
Funder name
Merck and Co Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12949718
Publication citations
-
Results
Fenwick SW, Toogood GJ, Lodge JP, Hull MA, The effect of the selective cyclooxygenase-2 inhibitor rofecoxib on human colorectal cancer liver metastases., Gastroenterology, 2003, 125, 3, 716-729.