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22 November 2008
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| [ Print-friendly version ] |
| Phase III randomised double-blind placebo controlled study of rofecoxib (VIOXX) in colorectal cancer patients following potentially curable therapy |
| ISRCTN | ISRCTN98278138 |
| ClinicalTrials.gov identifier | NCT00031863 |
| 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 |
| 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 | Countries of recruitment amended as of 26 July 2007: United Kingdom; Countries of recruitment provided at time of registration: International |
| 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 |
| research.services@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 01/07/2001 |
| Last edited | 24/01/2008 |
| Date ISRCTN assigned | 01/07/2001 |
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