TY - JOUR
T1 - Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial
T2 - Study protocol for a randomized controlled trial
AU - Poh, Catherine F.
AU - Durham, J. Scott
AU - Brasher, Penelope M.
AU - Anderson, Donald W.
AU - Berean, Kenneth W.
AU - MacAulay, Calum E.
AU - Lee, J. Jack
AU - Rosin, Miriam P.
N1 - Funding Information:
The authors would like to acknowledge Ms. Alisa Kami for the sharing of her clinical research experience; Ms. Yi-Ping (Kelly) Liu for the preparation of training manual; and all the research staff at the participating centres. We would like to thank Dr. Stuart Peacock, Health Economics and the CoDirector of the National Centre for Applied Research in Cancer Control (ARCC), and Dr. Kitty Corbett, Knowledge Translation and Health Communication Specialist, for their contribution of their expertise in the secondary objectives of the trial. The trial is supported by the Terry Fox Research Institution (2009-24), and the development work was supported by the Canadian Cancer Society (20336). CFP is supported by a Clinician Scientist Award from the CIHR and a Scholar Award from the Michael Smith Foundation for Health Research.
Funding Information:
Authors’ information CFP, Trial Principle Investigator, is an Oral Pathologist, a Clinician Scientist at the BC Cancer Research Centre (Departments of Integrative Oncology and Cancer Control Research) and an Associate Professor at the University of British Columbia (Faculty of Dentistry). She is the winner of the Clinician Scientist Award from the Canadian Institute of Health Research (2007-2010) and the Scholar Award of the Michael Smith Foundation for the Health Research (2007-2013). Her primary research focus involves application of molecular and imaging tools for screening, diagnosis, and management of cancerous and precancerous oral tissues. Her investigations also involve the impact of oral cancer screening in medically underserved communities. JSD, Trial Principle Investigator, is Clinical Professor and Acting Head, Division of Otolaryngology, Faculty of Medicine, the University of British Columbia. He is also Head and active staff of the Department of Otolaryngology, Vancouver Hospitals & Health Sciences Centre (Vancouver General Hospital and UBC Hospital), and a Consulting Surgical Oncologist, Head and Neck Tumor Group of the BC Cancer Agency. His research interests include Head and neck oncology and oromaxillofacial reconstructive surgery. PMB, Trial Biostatistician, is a Senior Research Scientist at UBC affiliated-Centre of Clinical Epidemiology and Evaluation (C2E2) and an associate member of the Department of Statistics at UBC. She is the Statistical Editor for the Canadian Journal of Anesthesia and has served on several grant review committees and ethics boards. Her research interests include clinical research methodology, secondary use of administrative data and statistical education. DWA is Clinical Professor, Division of Otolaryngology, Faculty of Medicine, the University of British Columbia. He is the Divisional Head of Otolaryngology for the Fraser Health Region Hospitals, an active staff of the Department of Otolaryngology, Vancouver Hospitals & Health Sciences Centre (Vancouver General Hospital and UBC Hospital), and a Consulting Surgical Oncologist, Head and Neck Tumor Group of the BC Cancer Agency. His research interests include Head and neck oncology and quality of life post head and neck surgery. KWB, Chair, Trial Pathology Committee, is an experienced head and neck pathologist. He is a Consultant Pathologist at Vancouver General Hospital. He is also a Clinical Professor with the University
PY - 2011/10/25
Y1 - 2011/10/25
N2 - Background: Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates.Method/Design: This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery.Discussion: In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system.Trial Registration: Clinicaltrials.gov NCT01039298.
AB - Background: Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates.Method/Design: This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery.Discussion: In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system.Trial Registration: Clinicaltrials.gov NCT01039298.
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U2 - 10.1186/1471-2407-11-462
DO - 10.1186/1471-2407-11-462
M3 - Article
C2 - 22026481
AN - SCOPUS:80054872933
SN - 1471-2407
VL - 11
JO - BMC cancer
JF - BMC cancer
M1 - 462
ER -