Pan-Canadian surgical study offers new hope for patients with early-stage oral cancer

Currently, about 30 per cent of patients who receive oral surgery have their cancer recur.  But a new, Canada-wide surgical trial using a new approach to remove tumours and pre-cancerous cells from the mouths of those diagnosed with early-stage oral cancer offers new hope for patients.

The Terry Fox Research Institute (TFRI) announces the launch of a $4.7 million Pan-Canadian Phase III clinical trial aimed at improving outcomes for patients undergoing surgery for oral squamous cell cancers.  The Canadian Optically Guided Approach for Oral Lesions Surgical Trial (The COOLS Study) has the potential to revolutionize clinical practice here and around the world for this kind of cancer.

"Our investment in this promising study is our response to a serious clinical concern expressed by head and neck surgeons across Canada and it has the potential to change surgical practices for cancer of the mouth nationally and internationally," said Dr. Victor Ling, TFRI President and Scientific Director.

Using a new surgical approach guided by an existing hand-held light tool, the surgeons, pathologists, and scientists involved in this nine-centre study will determine whether recurrence is reduced when they shift the surgical field for the removal of tumours or pre-cancerous cells in the mouth.

The surgeons will use fluorescence visualization (FV) or "blue light" provided by the optical aid rather than traditional white light to determine the tissue to be removed. Under the blue light, normal tissue generates a fluorescence which is absent in tumour or pre-cancerous tissue.  The study will aim to spare normal healthy tissue from surgery while catching high-risk, pre-cancerous tissue identified through FV.

"This study will have an immediate impact on practice if the study turns out the way we hope," says TFRI COOLS Study principal investigator Dr. Miriam Rosin, a senior scientist with the BC Cancer Agency who holds joint appointments at the University of British Columbia and Simon Fraser University. "If the study is successful, it will help to reduce the number of deaths from oral cancer as well as to improve the quality of life for people living with this disease. Working with scientists, we will have this new approach ready to disseminate to the surgical community at large and even globally."

"In work we've conducted to date in Vancouver, there has been almost no recurrence where surgery followed the contour of the lesion shown by using FV-guided surgery. Working together with surgeons, pathologists, research staff and scientists, this TFRI-funded study will enable us to test the approach on a broader cohort of patients at sites across the country and obtain the evidence required to change current practice." remarks principal investigator Dr. Catherine Poh, a senior scientist with BC Cancer Agency and oral pathologist and associate professor, University of British Columbia and oral pathologist and consulting dentist, Vancouver General Hospital.

This is the first Canadian study ever to bring together this group of clinicians to address a surgical challenge in oral cancer.  "Our surgical community has expressed great interest in participating in this trial which provides an unique and important opportunity to assess a surgical intervention in a controlled prospective manner across many sites," says principal investigator Dr. Scott Durham, an ear, nose and throat surgeon and clinical professor and head, division of otolaryngology, Vancouver General Hospital. The study aims to build a network of clinicians, pathologists and research staff across the country to fight oral cancer.

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