Overview

This trial is active, not recruiting.

Condition oral squamous cell carcinoma or severe dysplasia
Treatments resection of oral cancer
Sponsor University of Calgary
Collaborator Terry Fox Research Institute
Start date September 2011
End date October 2017
Trial size 40 participants
Trial identifier NCT02306967, UCENT004

Summary

Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer.
resection of oral cancer
Oral cancer will be resected.
resection of oral cancer
Oral cancer will be resected
(Experimental)
The oral resection will be guided by fluorescent visualization (FV).
resection of oral cancer
Oral cancer will be resected.
resection of oral cancer
Oral cancer will be resected

Primary Outcomes

Measure
disease specific survival
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - biopsy proven invasive oral cancer or severe dysplasia / Cis - invasive cancer must be T1 or T2 - no prior history of oral cancer / treatment of oral cancer Exclusion Criteria: - prior history of oral cancer - unable to provide informed consent - lesion not able to be completely visualized by FV

Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Calgary.