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Trial Title:
Buccal Cancer Resection Ultrasound Guided
NCT ID:
NCT05852665
Condition:
Buccal Mucosa Cancer
Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Conditions: Keywords:
Buccal mucosal carcinoma
Squamous cell carcinoma
Ultrasound
Multicenter
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Ultrasound-guided resection
Description:
Ultrasound-guided resection of buccal squamous cell carcinomas
Arm group label:
Ultrasound-guided surgery
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
Rijnstate Hospital
Agency class:
Other
Collaborator:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
Medisch Spectrum Twente
Agency class:
Other
Collaborator:
Agency:
Medical Center Haaglanden
Agency class:
Other
Collaborator:
Agency:
Antoni van Leeuwenhoek Ziekenhuis
Agency class:
Other
Source:
UMC Utrecht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05852665
