Abstract
BackgroundOral 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/DesignThis 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.DiscussionIn 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 RegistrationClinicaltrials.gov NCT01039298
Highlights
Oral cancer is a major health problem worldwide
In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the fluorescence visualization (FV) technology
Our preliminary results show that using FV to define the field at risk for surgical resection can result in a marked reduction in recurrence rates at 3 years (0/38 vs. 7/22) [14]
Summary
The COOLS trial is a multicenter, phase III randomized controlled trial comparing 2 surgery approaches, one guided with a optical device (VELscope; experimental arm) and one without (control arm), which is different from the conventional drug trial. The health economics goal will collect relative cost-effective evidence of the two treatments in both the cost per avoided recurrence and the cost per quality-adjusted life years gained and last but not the least, in the knowledge translation (KT) goal, we plan to develop a KT strategy that will facilitate rapid scale up of FV-guided surgery in Canada and beyond With such a comprehensive package, the COOLS trial promises to collect evidence and information necessary for bridging the gap from discovery to clinical application of FV-guided surgery into an oral cancer solution for patients worldwide. List of abbreviations BC: British Columbia; COOLS: Canadian Optically-guided approach for Oral Lesions Surgical; CRF: case report form; CT: computed tomography; DSMB: data safety monitoring board; FV: fluorescence visualization; FVS; FV Specialist; ICD: International Classification of Diseases; KT: knowledge translation; PanCanNOCC: pan-Canadian Network for Oral Cancer Control; RCT: randomized controlled trial; SC: site coordinator; SOP: standard operating procedure; SP: Site pathologist; SS: Site surgeon; TFRI: Terry Fox Research Institute; WL: white light
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