VICTOR PS – VIOXX® in colorectal cancer therapy: definition of optimal regime polyp sub-study
Sharon Love with Simon Bach (Oxford), Tariq Ismail (Birmingham), David Kerr (Oxford), Frank Sinicrope (USA), Justine Smith (Oxford), and Richard Cobb (Birmingham)The VICTOR-PS study is a companion protocol to the VICTOR trial. It is designed to assess the effects of COX-2 therapy upon the incidence and morphological type of metachronous adenoma recurrence among patients following ‘curative’ resection of colorectal cancer. VICTOR will enrol 5,000 subjects, randomly assigned to one of four treatment groups (n=1,250 per arm ): active rofecoxib 25 mg once daily (od) for 2 years; placebo rofecoxib 25 mg od for 2 years; active od for 5 years; or placebo od for 5 years. Colonoscopy will be performed pre-operatively or within 6 months of randomisation to clear the colorectum of neoplasia prior to administration of the study agent. Pill delivery, compliance monitoring, adverse event recording, and concomitant medication assessments will be conducted at regular intervals, as specified in the VICTOR trial protocol. Surveillance colonoscopy will be performed at about 24 and 60 months from the time of randomisation to identify and remove metachronous colorectal neoplasms. For patients in the VICTOR-PS sub-study polyps will be noted and those removed will be submitted to a central pathology lab. This sub-study aims to ask two questions:

Do COX-2 selective inhibitors reduce the incidence of metachronous adenoma recurrence in high risk individuals who have recently undergone resection of a colorectal cancer with curative intent?

Will analysis of recurrent adenomas (size, morphology, expression of molecular markers) help to define a COX-2 independent pathway of polyp formation?

This study was designed, achieved funding, achieved ethical approval and started accrual. However, towards the end of 2004, VIOXX® was withdrawn from the market and hence this study was stopped.