Clinical Trial: Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Canadian Optically Guided Approach for Oral Lesions Surgical Trial - COOLS
Brief Summary:
Oral squamous cell carcinoma (SCC) is a global disease responsible for ~300,000 new cancer cases each year. Local recurrence (~30% of cases) and formation of second primary malignancy are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease stage is often significant. These statistics underscore the urgent need to develop a better approach in order to control this deadly disease.
It is becoming increasingly apparent that oral cancers develop within wide fields of diseased tissue characterized by genetically altered cells that are widespread across the oral cavity and present in clinically and histologically normal oral mucosa. Complete removal of these lesions is difficult because high-risk changes frequently go beyond clinically visible tumor. In recognition of this, current 'best practice' is to remove SCC with a significant width (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease varies in size such approach often results in over-cutting (causing severe cosmetic and functional morbidity) or under removal of disease tissue, as evidenced by frequent positive surgical margins and high local and regional recurrence - a failure of the 'best practice.
There is a wealth of literature that supports the use of tissue autofluorescence in the screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This approach is already in clinical use in the lung and the mechanism of action of tissue autofluorescence has been well described in the cervix. Changes in fluorescence reflect a complex interplay of alterations to fluorophores in the tissue and structural changes in tissue morphology, each associated with progression of the disease.
As one of the internationally leading teams in app
Detailed Summary:
1.0. OBJECTIVES AND APPROACHES: 1.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the recurrence-free survival of histologically confirmed disease within the context of a randomized controlled trial (efficacy).
Hypothesis: FV-guided surgery will increase the recurrence-free survival. Approaches: This Aim requires the establishment of a randomized controlled trial of 200 patients which will compare outcome for patients in 2 arms: one with conventional surgery with margin delineated under white light, and the other using FV guidance for margin delineation. Please see attached Appendix 1 for a step-by-step protocol. This comprises a multidisciplinary team of surgeons, pathologists, project coordinators, and FV Specialists. In addition to the presurgery assessment, all participating patients will have 3-month follow-ups for the first 2 years and 6-month for the rest of the study period. Biopsy will occur when clinically warranted or at 2-year post-surgery.
1.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented for this approach and assess quality of life issues.
Hypothesis: FV-guided surgery can be delivered in a cost effective manner and improve the quality of life of patients.
Approaches: This aim requires the collection of economic and quality of life (QoL) data to establish the cost per recurrence prevented for FV-guided surgery and to assess quality of life impacts. To asses potential psychosocial consequences of FV-guided surgery we will measure global QoL. We will use the validated EQ-5D and Functional Assessment of Cancer Therapy Head and Neck Module (FACT-H&N) to determine the participant's QoL at each assessment. The questionnaires will be applie
Sponsor: University of British Columbia
Current Primary Outcome: Recurrence-free survival [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Histological and molecular evidence of positive margins and quality of life [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: University of British Columbia
Dates:
Date Received: December 22, 2009
Date Started: January 2013
Date Completion: June 2015
Last Updated: September 8, 2014
Last Verified: September 2014
