Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Oct 25:11:462.
doi: 10.1186/1471-2407-11-462.

Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

Catherine F Poh  1 , J Scott Durham, Penelope M Brasher, Donald W Anderson, Kenneth W Berean, Calum E MacAulay, J Jack Lee, Miriam P Rosin
Affiliations
Randomized Controlled Trial

Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

Catherine F Poh et al. BMC Cancer. .

Abstract

Background: Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates.

Method/design: This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery.

Discussion: In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system.

Trial registration: Clinicaltrials.gov NCT01039298.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial schema. A total of 400 subjects (240 invasive squamous cell carcinoma and 160 severe dysplasia or carcinoma in situ) will be randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up.
Figure 2
Figure 2
Flow chart of key steps and the involvement of key personnel in each steps and site coordinator's role.
See this image and copyright information in PMC

References

    1. Ferlay J, Bray F, Pisani P, Parkin D. IARC Cancer Base No. 5 Version 2.0. Lyon, France: IARCPress; 2004. GLOBOCAN 2002. Cancer incidence, mortality and prevalence worldwide.
    1. Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005;365(9475):1927–1933. doi: 10.1016/S0140-6736(05)66658-5. - DOI - PubMed
    1. Mariotto AB, Rowland JH, Ries LAG, Scoppa S, EJ F. Multiple cancer prevalence: a growing challenge in long-term survivorship. Cancer Epidemiol Biomarkers Prev. 2007;16:566–571. doi: 10.1158/1055-9965.EPI-06-0782. - DOI - PubMed
    1. Dhooge IJ, De Vos M, Van Cauwenberge PB. Multiple primary malignant tumors in patients with head and neck cancer: results of a prospective study and future perspectives. Laryngoscope. 1998;108(2):250–256. doi: 10.1097/00005537-199802000-00017. - DOI - PubMed
    1. Braakhuis BJ, Tabor MP, Kummer JA, Leemans CR, Brakenhoff RH. A genetic explanation of Slaughter's concept of field cancerization: evidence and clinical implications. Cancer Res. 2003;63(8):1727–1730. - PubMed

Publication types

Associated data