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Phase III randomised double-blind placebo controlled study of rofecoxib (VIOXX) in colorectal cancer patients following potentially curable therapy
ISRCTN ISRCTN98278138
DOI 10.1186/ISRCTN98278138
ClinicalTrials.gov identifier NCT00031863
EudraCT number
Public title Phase III randomised double-blind placebo controlled study of rofecoxib (VIOXX) in colorectal cancer patients following potentially curable therapy
Scientific title
Acronym VICTOR - Vioxx In Colorectal cancer Therapy: definition of Optimal Regime
Serial number at source VICTOR
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
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Colorectal cancer
Participants - 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
Participants - 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
Anticipated start date 30/04/2002
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material
Target number of participants 7000
Interventions 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.
Primary outcome measure(s) Added as of 24 January 2008:
Overall Survival
Secondary outcome measure(s) Added as of 24 January 2008:
1. Relapse-free survival
2. Thrombotic cardiovascular safety
Sources of funding 1. Cancer Research UK
2. Merck and Co Inc
Trial website
Publications Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17652651
Contact name Prof  David J   Kerr
  Address Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
Headington
  City/town Oxford
  Zip/Postcode OX3 7DQ
  Country United Kingdom
Sponsor University of Oxford (UK)
  Address University Offices
Wellington Square
  City/town Oxford
  Zip/Postcode OX1 2JD
  Country United Kingdom
  Tel +44 (0)1865 270 000
  Email research.services@admin.ox.ac.uk
  Sponsor website: http://www.ox.ac.uk
Date applied 01/07/2001
Last edited 11/08/2011
Date ISRCTN assigned 01/07/2001
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