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. “We look forward to a study that will provide the evidence for surgical practice that this approach will greatly reduce recurrence among these patients.”
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 generatesa 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.
“There are no side effects associated with using the fluorescent light and the use of this tool will only add about 20 minutes to the surgical procedure time,” said Calgary’s site lead, University of Calgary’s Dr. Joseph Dort.
Dort went on to say that the involved investigators believe the fluorescent visualization will result in higher cure rates for this particular type of cancer and that belief has been supported by preliminary data. Validation of the data is however required to be carried out through a randomized clinical trial.
“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.
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.