Vancouver, BC – The Terry Fox Research Institute (TFRI) has announced 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 Dr Miriam Rosin, TFRI COOLS Study principal investigator and 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.”
The study is the first in Canada 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 a unique and important opportunity to assess a surgical intervention in a controlled prospective manner across many sites,” says Dr Scott Durham principal investigator, 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.
Lead investigators in the $4,734.469 study are as follows:
– Dr Miriam Rosin, Principal investigator (director of the British Columbia Oral Cancer Prevention Program; senior scientist, BC Cancer Agency; professor, biomedical physiology and kinesiology, Simon Fraser University and professor, pathology and laboratory medicine, University of British Columbia
– Dr Catherine Poh, Principal investigator (oral pathologist, BC Provincial Oral Biopsy Service; senior scientist, BC Cancer Agency; associate professor, Faculty of Dentistry, University of British Columbia; oral pathologist, anatomical pathology and consulting dentist in dentistry at Vancouver General Hospital).
– Dr Scott Durham, Principal investigator (head, Department of Otolaryngology, Vancouver General Hospital; clinical professor and head, Division of Otolaryngology, Faculty of Medicine, University of British Columbia; consulting surgical oncologist, BC Cancer Agency )
– Dr Calum MacAulay, Project imaging lead (head, Integrative Oncology Department, BC Cancer Agency; professor, Pathology/Laboratory Medicine and Physics and Astronomy departments, University of British Columbia)
– Dr Stuart Peacock, Health economist (co-director, Canadian Centre for Applied Research in Cancer Control (ARCC), associate professor, University of British Columbia) and Dr Jeffrey Hoch Health economist (co-director, ARCC)
– Dr Kitty Corbett, knowledge translation and public health communication specialist (professor, Faculty of Health Sciences, Simon Fraser University)