Buccal Cancer Resection Ultrasound Guided

Squamous Cell Carcinoma Clinical Trial

— BRUG  

Official title:

Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852665
• Other study ID #: NL83714.041.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2023
• Source: UMC Utrecht
• Contact: Carleen Adriaansens, MSc
• Phone: 088-7567805
• Email: c.m.e.m.adriaansens-2[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• buccal mucosal squamous cell carcinoma

• surgical removal under general anesthesia

Exclusion Criteria:

• tumor is not visible on ultrasound as echolucent region

Related Conditions & MeSH terms

• Buccal Mucosa Cancer
• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Device:
• Ultrasound-guided resection
Ultrasound-guided resection of buccal squamous cell carcinomas

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
UMC Utrecht	Antoni van Leeuwenhoek Ziekenhuis, Medical Center Haaglanden, Medisch Spectrum Twente, Rijnstate Hospital, University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of involved margins	Number of involved margins	within 2 weeks after surgery
Secondary	Sensitivity and specificity of ultrasound for identifying involved margins	accuracy of ultrasound	within 2 weeks after surgery
Secondary	Number of patients with an indication for local adjuvant therapy	need for local adjuvant treatment	within one month after surgery
Secondary	Quality of life assessed by questionnaires at 4 timepoints	Influence of treatment on quality of life	before surgery, at 4, 8, and 12 months after surgery