Method: Funded by the Terry Fox Research Institute (TFRI), the COOLS study is a multi-centre phase III randomized controlled trial with a total of 400 patients. From September 2010, 7 cancer centres, including Vancouver, London, Halifax, Calgary, Toronto (Sunnybrook Hospital), Winnipeg, and Edmonton have joined the COOLS trial and are actively recruiting eligible patients across Canada. Each eligible patient will complete baseline questionnaires on socio-demographic factors, risk factors, cancer history, and quality of life prior to the surgery. Clinical assessment with FV images is also collected.
Result: Up to the end of September, 2012, 183 patients (82% of the projected to date) have received assigned surgical interventions, including 105 squamous cell carcinoma and 78 high-grade lesions (severe dysplasia and carcinoma in situ). Two patients have reached the primary endpoint, local recurrence; eight patients have failed the first pass margin and received salvage surgeries; eight patients developed regional lymph node metastasis at the time of surgery (N=6) or at follow-up (N=2); and two patients have died of disease. No patient has withdrawn from the trial and completion rate for data collection is approximately 90%. Additionally, screening logs have been used to monitor site accrual activities. Quality assurance for the adoption of the new technology is reinforced through constant reviewing pre-surgical and surgical images taken at the initial and intraoperative assessments.
Conclusion: The trial is not only an excellent example of translational research but also an integral in building the first-ever pan Canadian surgical network for oral cancers.