Phase III randomised double-blind placebo controlled study of rofecoxib (VIOXX) in colorectal cancer patients following potentially curable therapy

ISRCTN	ISRCTN98278138
DOI	https://doi.org/10.1186/ISRCTN98278138
ClinicalTrials.gov (NCT)	NCT00031863
Protocol serial number	VICTOR
Sponsor	University of Oxford (UK)
Funders	Cancer Research UK, Merck and Co Inc

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David J Kerr
Scientific

Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
Headington
Oxford
OX3 7DQ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	VICTOR - Vioxx In Colorectal cancer Therapy: definition of Optimal Regime
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Vioxx (rofecoxib)
Primary outcome measure(s)	Added as of 24 January 2008: Overall Survival
Key secondary outcome measure(s)	Added as of 24 January 2008: 1. Relapse-free survival 2. Thrombotic cardiovascular safety
Completion date	30/09/2004
Reason abandoned (if study stopped)	Vioxx withdrawn

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	7000
Key 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
Key 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
Date of first enrolment	30/04/2002
Date of final enrolment	30/09/2004

Department of Clinical Pharmacology

Oxford
OX3 7DQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	26/07/2007		Yes	No