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| [ ...Back to search results ] | [ Print-friendly version ] |
| Phase III randomised double-blind placebo controlled study of rofecoxib (VIOXX) in colorectal cancer patients following potentially curable therapy |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN98278138 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | VICTOR |
| 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 |
| Disease/condition/study domain | Colorectal cancer |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | 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. |
| Countries of trial | Countries of recruitment amended as of 26 July 2007: United Kingdom; Countries of recruitment provided at time of registration: International |
| 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 |
| Patient information material | |
| Anticipated start date | 30/04/2002 |
| Anticipated end date | 30/09/2004 |
| Status of trial | Completed |
| 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 |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17652651 |
| Sources of funding | 1. Cancer Research UK 2. Merck and Co Inc |
| Sponsor name | University of Oxford (UK) |
| Sponsor details | University Offices Wellington Square Oxford United Kingdom OX1 2JD |
| Sponsor telephone | +44 (0)1865 270 000 |
| Sponsor email | research.services@admin.ox.ac.uk |
| Sponsor website | http://www.ox.ac.uk |
| Contact name | Prof David J Kerr |
| Contact details | Department of Clinical Pharmacology Old Road Campus Research Building University of Oxford Old Road Campus Headington Oxford United Kingdom OX3 7DQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN98278138 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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