Buccal Cancer Resection Ultrasound Guided (BRUG)
Primary Purpose
Buccal Mucosa Cancer, Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided resection
Sponsored by
About this trial
This is an interventional treatment trial for Buccal Mucosa Cancer focused on measuring Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter
Eligibility Criteria
Inclusion Criteria: buccal mucosal squamous cell carcinoma surgical removal under general anesthesia Exclusion Criteria: tumor is not visible on ultrasound as echolucent region
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound-guided surgery
Arm Description
Outcomes
Primary Outcome Measures
Number of involved margins
Number of involved margins
Secondary Outcome Measures
Sensitivity and specificity of ultrasound for identifying involved margins
accuracy of ultrasound
Number of patients with an indication for local adjuvant therapy
need for local adjuvant treatment
Quality of life assessed by questionnaires at 4 timepoints
Influence of treatment on quality of life
Full Information
NCT ID
NCT05852665
First Posted
April 18, 2023
Last Updated
May 1, 2023
Sponsor
UMC Utrecht
Collaborators
Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis
1. Study Identification
Unique Protocol Identification Number
NCT05852665
Brief Title
Buccal Cancer Resection Ultrasound Guided
Acronym
BRUG
Official Title
Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.
Detailed Description
Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.
The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.
In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.
50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buccal Mucosa Cancer, Squamous Cell Carcinoma
Keywords
Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-guided surgery
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasound-guided resection
Intervention Description
Ultrasound-guided resection of buccal squamous cell carcinomas
Primary Outcome Measure Information:
Title
Number of involved margins
Description
Number of involved margins
Time Frame
within 2 weeks after surgery
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of ultrasound for identifying involved margins
Description
accuracy of ultrasound
Time Frame
within 2 weeks after surgery
Title
Number of patients with an indication for local adjuvant therapy
Description
need for local adjuvant treatment
Time Frame
within one month after surgery
Title
Quality of life assessed by questionnaires at 4 timepoints
Description
Influence of treatment on quality of life
Time Frame
before surgery, at 4, 8, and 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
buccal mucosal squamous cell carcinoma
surgical removal under general anesthesia
Exclusion Criteria:
tumor is not visible on ultrasound as echolucent region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carleen Adriaansens, MSc
Phone
088-7567805
Email
c.m.e.m.adriaansens-2@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Noorlag
Email
r.noorlag-3@umcutrecht.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Buccal Cancer Resection Ultrasound Guided
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