The aim of this research is to decrease the number of involved margins, resulting in less adjuvant therapy and less local recurrences.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of involved margins (<1 mm).
Secondary outcome
The accuracy of the ultrasound for measuring tumor thickness
Need for adjuvant therapy
The influence of treatment on the quality of life
Background summary
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.
Study objective
The aim of this research is to decrease the number of involved margins,
resulting in less adjuvant therapy and less local recurrences.
Study design
In this trial, 70 patients with a squamous cell carcinoma of the buccal mucosa
will be included for treatment with ultrasound-guided resection. This is a
prospective, non randomized trial.
Intervention
Ultrasound-guided resection of buccal mucosa carcinomas
Study burden and risks
Ultrasound is a non-invasive form of imaging with no harmful effect. The use of
ultrasound during surgery might lead to more removal of healthy tissue,
however, this may lead to less involved margins and adjuvant therapy. The
anesthesia time will last 5-10 minutes longer. Furthermore, on 4 timepoints
(before the operation and 3x in the year after operation) questionnaires will
be send.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- >=18 years
- Tumors of the buccal mucosa
- Histologically proven squamous cell carcinoma
- Whole tumor can be visualized by ultrasound
- Surgical removal under general anesthesia
Exclusion criteria
- Tumor is located in the retromolar areas
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT05852665 |
CCMO | NL83714.041.23 |