Sponsor: University of Oxford
EudraCT number: 2004-000657-39
Post-treatment stage of a Phase III, randomised, double blind, placebo-controlled study of rofecoxib (VIOXX®) in colorectal cancer patients following potentially curative therapy.
The trial’s aim was to answer the question of whether VIOXX®, a potent orally active COX-2 inhibitor licensed for use in osteoarthritis, has a role as maintenance therapy in colorectal cancer patients following potentially curative therapy. Patients were randomised to receive VIOXX® or placebo (blinded), given for two or five years (not blinded) to address the question of optimum duration.
The VICTOR study opened on 09 Apr 2002. The goal was to recruit 7000 patients over 5 years with 250 sites based in the UK, USA and Australia, with the study finally completing in 2010. On 30 Sep 2004 the trial was closed to recruitment and all patients were taken off study drug, in response to the worldwide withdrawal of VIOXX® by Merck & Co. Inc. This was due to another study using VIOXX® (the APPROVe trial), which had found an increased relative risk of cardiovascular (CV) incidents in patients on VIOXX® for periods longer than 18 months.
Please refer to the publications section for details of the paper published, looking at the CV risk posed to the patients on the VICTOR trial.
Recruited number: 2434 patients
Follow up completed in May 2009.
Click here for list of participating sites
Follow-up for VICTOR has now finished. The deadline for collecting and entering data was 31 Aug 2009. Please note; invoices dated later than 28 Feb 2010 are no longer accepted for payment.
SITE CLOSE-OUT IS NOW COMPLETE
All participating sites have now been closed and the Investigator and Pharmacy Files should be archived a per local site policy. Each site will have received a notification of successful closeout, along with the End Of Trial Notification from the MHRA and the VICTOR trial publications (please refer to publications section) which were submitted as the End of Study Report.
We take this opportunity to thank you again for the tremendous effort you showed in helping us get as much data in as possible, before we closed.
Treatment with VIOXX® will result in improved overall survival compared with placebo.
Treatment with VIOXX® will result in improved disease-free survival compared with placebo.
Follow up completion: May 2009
Final analysis and publication: 2010
Trial duration: 7 years