Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00031863
Protocol/serial number
VICTOR
Study information
Scientific title
Acronym
VICTOR - Vioxx In Colorectal cancer Therapy: definition of Optimal Regime
Study hypothesis
Added as of 24 January 2008:
1. Treatment with VIOXX® will result in improved overall survival compared with placebo
2. Treatment with VIOXX® will result in improved disease-free survival compared with placebo
Countries of recruitment amended as of 26 July 2007: Countries of recruitment provided at time of registration: International
Ethics approval
Added as of 26 July 2007: Approved by Clinical Trials Committee of the Cancer Research Campaign, the West Midlands Multicenter Research Ethics Committee, and local research ethics committees at participating centers.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Colorectal cancer
Intervention
1. VIOXX: 25 mg once daily
2. Placebo: identical in appearance, once daily
As of 26 July 2007: Please note that this trial was terminated prematurely in September 2004 due to worldwide withdrawal of rofecoxib.
Intervention type
Drug
Phase
Phase III
Drug names
Vioxx (rofecoxib)
Primary outcome measures
Added as of 24 January 2008:
Overall Survival
Secondary outcome measures
Added as of 24 January 2008:
1. Relapse-free survival
2. Thrombotic cardiovascular safety
Overall trial start date
30/04/2002
Overall trial end date
30/09/2004
Reason abandoned
Vioxx withdrawn
Eligibility
Participant inclusion criteria
1. Histologically proven Dukes Stage C (Stage III any T, N1-2, M0) or B (Stage II, T3 or 4, N0, M0) colorectal carcinoma
2. Complete resection of primary tumour without gross microscopic evidence of residual disease
3. World Health Organisation zero to one
4. Acceptable haematological and biochemical function
5. Within 12 weeks of finishing potentially curative therapy (Surgery +/- radiotherapy +/- chemotherapy)
6. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
7000
Participant exclusion criteria
Exclusion criteria added as of 26 July 2007:
1. Active peptic ulceration or gastrointestinal bleeding in the past year
2. History of adverse reactions to NSAIDs
3. Known sensitivity to rofecoxib
4. Those receiving long-term NSAID therapy (except for low-dose aspirin, =100 mg per day)
5. Younger than 18 years
6. Women who were pregnant, lactating, or premenopausal but not using contraception. 7. History of cancer (other than adequately treated in situ carcinoma of the cervix or basal or squamous-cell carcinoma), inflammatory bowel disease, or severe congestive heart failure
Recruitment start date
30/04/2002
Recruitment end date
30/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Pharmacology
Oxford
OX3 7DQ
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270 000
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Merck and Co Inc
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
Publication citations
-
Results
Kerr DJ, Dunn JA, Langman MJ, Smith JL, Midgley RS, Stanley A, Stokes JC, Julier P, Iveson C, Duvvuri R, McConkey CC, , Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer., N. Engl. J. Med., 2007, 357, 4, 360-369, doi: 10.1056/NEJMoa071841.