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Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of British Columbia
Sponsor:
Collaborators:
Terry Fox Research Institute
British Columbia Cancer Agency
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01039298
First received: December 22, 2009
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 applying tissue fluorescence technology, we have shown that direct fluorescence visualization (FV) tools can identify clinically visible or occult premalignant and malignant lesions that are associated with lesions at risk, with high-grade histology and high-risk molecular change. In a recently small scaled, retrospective study, we have shown that FV helped surgeons in the operating room to determine the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower 2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach). There is need to design a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence in proving the efficacy of the surgery approach using this adjunct tool.

To establish the evidence supporting the change in clinical practice using FV-guided surgery. There are 3 objectives.

2.1. 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.

2.2. 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 2.3 Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated molecular markers (microsatellite analysis, LOH) and histological change (quantitative pathology) in surgical margins in a nested case-control study involving a tumor bank created within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time improving capture of high-risk tissue.


Condition Intervention Phase
Oral Cancer
High-grade Precancer
Procedure: Fluorescence visualization device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Canadian Optically Guided Approach for Oral Lesions Surgical Trial - COOLS

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Histological and molecular evidence of positive margins and quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

All subjects in this study will receive surgery to treat their oral lesions. The margins (or boundaries) of the tissue to be removed during surgery will be defined by 2 different procedures (or study arms) in the operating room.

The Control arm. Surgical boundaries for oral lesions will be defined under regular white light.

Procedure: Fluorescence visualization device
The trial will randomize 200 patients - 100 in the FV arm (using FV guided the surgery margin)
Experimental: B

All subjects in this study will receive surgery to treat their oral lesions. The margins (or boundaries) of the tissue to be removed during surgery will be defined by 2 different procedures (or study arms) in the operating room.

The FV arm (experimental arm). Surgical boundaries for oral lesions will be defined by FV.

Procedure: Fluorescence visualization device
The trial will randomize 200 patients - 100 in the control arm (using conventional white light approach).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with severe dysplasia, carcinoma in situ, invasive squamous cell carcinoma (T1 or T2) of the oral cavity (ICO-D site codes: C02.0-C06.9) who will be undergoing curative resection (primary disease).

Exclusion Criteria:

  • Patients with a non-oral malignancy diagnosed (not including non-melanoma skin cancer and lymphoma outside of head and neck region) within the past 3 years.
  • Patients with evidence of distant metastasis (as determined by CAT and X-ray) at the time of recruitment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039298

Contacts
Contact: Helen Chiu 604-675-8057 hchiu@bccancer.bc.ca
Contact: Sylvia Lam 604-675-8057 sau@bccancer.bc.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Joseph Dort, Dr.       jcdort@gmail.com   
Canada, British Columbia
BC Cancer Agency (Vancouver & Fraser Valley Centres) & Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Helen Chiu    604-675-8057    hchiu@bccancer.bc.ca   
Contact: Sylvia Lam    604-675-8057    sau@bccancer.bc.ca   
Canada, Manitoba
CancerCare Manitoba, University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Paul Kerr, Dr.       Pkerr@exchange.hsc.mb.ca   
Canada, Nova Scotia
Victoria General Hospital, Dalhousie University Recruiting
Halifax, Nova Scotia, Canada
Contact: Rob Hart, Dr.       drrobhart@hotmail.com   
Canada, Ontario
London Health Science Centre, University of Western Ontario Recruiting
London, Ontario, Canada
Contact: John Yoo, Dr.       John.yoo@lhsc.on.ca   
Ottawa General Hospital, University of Ontario Recruiting
Ottawa, Ontario, Canada
Contact: Mike Odell, Dr.       lesandmike@hotmail.com   
Sunnybrook Hospital Recruiting
Toronto, Ontario, Canada
Contact: Kevin Higgins, Dr.       kevin.higgins@sunnybrook.ca   
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Karen Kost, Dr.       kmkost@yahoo.com   
Sponsors and Collaborators
University of British Columbia
Terry Fox Research Institute
British Columbia Cancer Agency
Investigators
Principal Investigator: Catherine Poh, DDS, PhD University of British Columbia
Principal Investigator: Scott Durham, Dr. University of British Columbia
Principal Investigator: Miriam Rosen, Ph.D Simon Fraser University
Study Director: Calum MacAulay, Ph.D BC Cancer Agency Research Centre
Study Director: Penelope Brasher, Ph.D University of British Columbia
Study Director: Stuart Peacock, Ph.D BC Cancer Agency Research Centre
Study Director: Kitty Corbett, Ph.D Simon Fraser University
Study Director: Kenneth Berean, Dr. University of British Columbia
Study Chair: Donald Anderson, Dr. University of British Columbia
Study Chair: Michele Williams, DDS British Columbia Cancer Agency
Study Chair: Joseph Dort, Dr. University of Calgary
Study Chair: Robert Hart, Dr. Dalhousie University
Study Chair: Mike Odell, Dr. University of Ontario
Study Chair: Paul Kerr, Dr. University of Manitoba
Study Chair: John Yoo, Dr. University of Western Ontario, Canada
Study Chair: Kevin Higgins, Dr. Sunnybrook Hospital
Study Chair: Karen Kost, Dr. McGill University Health Center
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01039298     History of Changes
Other Study ID Numbers: H09-03090
Study First Received: December 22, 2009
Last Updated: September 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Oral cancer
fluorescence visualization
surgical margin
recurrence

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014