VICTOR

Post-treatment stage of a Phase III, randomised, double blind, placebo-controlled study of rofecoxib (VIOXX®) in colorectal cancer patients following potentially curative therapy.

EudraCT number: 2004-000657-39
Chief Investigator: Prof David J. Kerr
Sponsor: University of Oxford

The trial’s aim is 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 the 9th April 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 2012. On the 30th September 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 incidents in patients on VIOXX® for periods longer than 18 months. We are in the process of publishing a paper with a leading journal, which looks at the CV risk posed to the patients on the VICTOR trial.

STUDY STATUS

Closed
Recruited number: 2434 patients
Follow up completed in December 2009.

Click <here> for list of participating sites

Follow-up for VICTOR has now finished. The deadline for collecting and entering data was 31^st August 2009 and we are now, with your help, closing each site and preparing for archiving. 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.

Site Close-out

What Should Sites Be Doing…..?

In order to prepare your files for archiving, the monitors will have contacted each site to explain the close-out process and offer any assistance. In return, we should have received a fully completed checklist for the Investigator Site File and the Pharmacy File. Any missing documents can be found in the restricted area of the website and filed appropriately. On completion, sites will have received a close-out notification indicating you have completed the checklist successfully and your files are now ready for archiving.

We asked that all checklists be returned by 29th January 2010, and you were informed all outstanding site payments would be processed following successful site closure. Please return any outstanding checklists (completed and signed) immediately. Contact the trial coordinator or any member of the QA team if you have any questions or concerns, and many thanks to everyone who has completed this procedure. Invoices (dated no later than 28 February 2010) for final payments are now being requested from these sites.

STUDY SCHEMA

STUDY OBJECTIVES

Primary:

Treatment with VIOXX^®will result in improved overall survival compared with placebo.

Secondary:

Treatment with VIOXX^® will result in improved disease-free survival compared with placebo.

KEY DATES

Follow up completion: Dec 2009
Final analysis and publication: 2016
Trial duration: 7 years

Victor Trial Office (OCTO)

Randomisation Service Mon-Fri 9-5 (UK Time): UK Tel: 0800 389 1635, UK Fax: 0800 389 1629 (24hrs) Non UK Tel: +44 (0)1865 617 014, Non UK Fax: +44 (0)1865 617 015 (24hrs) Enquiries: Tel: +44 (0)1865 617 012, Fax: +44 (0)1865 617 010 Email: enquiries@victor-trial.org.uk Website: www.octo-oxford.org.uk