Colorectal cancer Cancer Colorectal cancer
Conditions
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 o
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 24 January 2008: Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 24 January 2008: 1. Relapse-free survival 2. Thrombotic cardiovascular safety | — |
Countries
United Kingdom
Outcome results
None listed