Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
11/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David J Kerr

ORCID ID

Contact details

Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
Headington
Oxford
OX3 7DQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00031863

Protocol/serial number

VICTOR

Study information

Scientific title

Acronym

VICTOR - Vioxx In Colorectal cancer Therapy: definition of Optimal Regime

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Vioxx (rofecoxib)

Primary outcome measures

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 trial start date

30/04/2002

Overall trial end date

30/09/2004

Reason abandoned

Vioxx withdrawn

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7000

Participant 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

Recruitment start date

30/04/2002

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Pharmacology
Oxford
OX3 7DQ
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270 000
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Industry

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Merck and Co Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17652651

Publication citations

  1. Results

    Kerr DJ, Dunn JA, Langman MJ, Smith JL, Midgley RS, Stanley A, Stokes JC, Julier P, Iveson C, Duvvuri R, McConkey CC, , Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer., N. Engl. J. Med., 2007, 357, 4, 360-369, doi: 10.1056/NEJMoa071841.

Additional files

Editorial Notes