May 26, 2011
Study findings may change surgical practice
Pan-Canadian Surgical Study Offers New Hope for Patients with Early-Stage Oral Cancer
Vancouver, BC – 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 a unique
and important opportunity to assess a surgical intervention in a controlled prospective manner across many sites,”
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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.
About The Terry Fox Research Institute:
Launched in October 2007, The Terry Fox Research Institute is the research arm of The Terry Fox Foundation. TFRI
seeks to improve significantly the outcomes of cancer research for the patient through a highly collaborative,
team-oriented, milestone-based approach to research that will enable discoveries to translate quickly into
practical solutions for cancer patients worldwide. TFRI collaborates with over 50 cancer hospitals and research
organizations across Canada as MOU partners. TFRI headquarters are in Vancouver, BC. www.tfri.ca
NOTE TO MEDIA: PRINICIPAL INVESTIGATORS AVAILABLE FOR INTERVIEWS: ORAL CANCER
SURVIVOR AVAILABLE FOR INTERVIEW
B-REEL AVAILABLE
For more information, contact:
Kelly Curwin
Chief Communications Officer
604-675-8223
C: 778-237-8158
kcurwin@tfri.ca
PHOTO/VIDEO and INTERVIEW OPPORTUNITY: THURSDAY, MAY 26, 2011
FLUORESCENCE VISUALIZATION (BLUE-LIGHT) DEMONSTRATION
9am, BC Cancer Agency
Please meet in front lobby of BC Cancer Agency Vancouver Centre
600 West 10th Avenue
COOLS study principal investigator Dr. Catherine Poh will demonstrate the Fluorescence Visualization (Blue Light)
Tool at a demonstration in the Oral Oncology laboratory with a former patient who underwent oral surgery four years
ago. Dr. Poh will also make available clinical images depicting lesions as seen under white light and flourescence
visualization. Both Dr. Poh and the cancer survivor will be available during this time to be interviewed by media.
For more information, or to attend this demonstration, please contact:
Allison Colina
BC Cancer Agency
t. 604-861-8079
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Lisa Carver
Vancouver Coastal Research
t. 604-319-7533
BACKGROUNDER
The Canadian Optically Guided Approach for Oral Lesions Surgical Trial (COOLS Study)
Total Invested: $4,734.469
Study Leads:
 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)
About the Study
Primary Objective: The primary objective is to determine whether a simple hand-held light device to guide
surgery can reduce oral cancer recurrence
Design: Double-blinded, controlled randomized Phase III study
Duration: 5 years
Participants: Patients diagnosed with severe dysplasia, carcinoma in situ and invasive squamous cell
carcinoma and undergoing surgery treatment with intent to cure.
Led by Vancouver-based clinicians and scientists, this pan-Canadian study will recruit 400 patients from across
Canada over the next two years; study teams at the nine sites will continue to follow their patients’ progress
for an additional three years to determine if there is any recurrence. Teams of clinicians and scientists have
been formed at each site and they include surgeons, pathologists, dental specialists, and research nurses and
coordinators. Participating surgeons will recruit eligible patients.
As part of the study, health economists will collect health economic evidence and data relative to the costeffectiveness of the study and cost per quality of adjusted life years gained. As well, a knowledge translation
specialist will partner with the team to collect and exchange health service information and develop plans to
apply, both in Canada and abroad, the knowledge gained.
Specialized Fluorescence Flash Camera: A special, user-friendly “all in one” camera has been developed
which will allow the FV specialist to automatically capture clinical lesion images under white light and
fluorescence visualization without needing changes to filters or settings.
Participating Sites
City
Vancouver
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Institutions/Agencies
University of British Columbia, Simon Fraser University, Vancouver
Edmonton
Calgary
General Hospital/Vancouver Coastal Health , BC Cancer Agency
University of Alberta Hospital
University of Calgary and Affiliated Health Sciences Centres
Southern Alberta Cancer Research Institute
University of Manitoba
CancerCare Manitoba
Winnipeg
Toronto
Sunnybrook Health Sciences Centre
London
University of Western Ontario
London Health Sciences Centre
University of Ottawa
The Ottawa Hospital
McGill University Health Centre
Ottawa
Montreal
Halifax
Dalhousie University
QEII Health Sciences Centre (Victorial General Hospital)
ABOUT ORAL CANCER
In Canada, it is estimated that 3,400 Canadians are diagnosed with oral cancer every year. In 2010, the estimated
number of deaths due to oral cancer was 1,150. (Source: Canadian Cancer Society, 2010) Surgery is often used to
treat oral cancer. Reconstructive surgery may be needed after the surgeon removes the tumour and some healthy
tissue around it. If the cancer has spread, surgery may be required in other areas such as the neck, lymph nodes
and throat.
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