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 number | NCT00031863 |
| Secondary identifying numbers | VICTOR |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 11/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David J Kerr
Scientific
Scientific
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
Headington
Oxford
OX3 7DQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Vioxx (rofecoxib) |
| Primary outcome measure | 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 study start date | 30/04/2002 |
| Completion date | 30/09/2004 |
| Reason abandoned (if study stopped) | Vioxx withdrawn |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Pharmacology
Oxford
OX3 7DQ
United Kingdom
OX3 7DQ
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270 000 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Merck and Co Inc
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 26/07/2007 | Yes | No |
