UltraSound-guided resection of tongue cancer - Multicenter

Tongue cancer is preferably treated by surgical resection. Free margins (>=5 mm)
are essential for local control. In case margins are close (1-5 mm) or positive
(<1 mm), adjuvant treatment, i.e. a re-resection or (chemo)irradiation, is
often indicated. Postoperative irradiation can have a serious effect on quality
of life due to significant morbidity and (oral) discomfort (i.e. mucositis,
fibrosis and osteoradionecrosis). In case of re-resections, relocating close or
positive margins based on histopathological data is challenging. Moreover, it
increases healthcare costs. Recently, a historical cohort of patients
surgically treated for pT1-pT3 tongue cancer in the UMC Utrecht was analyzed.
It revealed that only 18% patients had free resection margins. As a result, 30%
of the patients had local adjuvant treatment, 9% re-resection and 21%
irradiation.

To improve local control and to reduce adjuvant treatment, there is a need for
a method that provides intra-operative feedback about the distance between the
tumor and resection plane (margin distance). At the moment, this distance is
estimated by palpation. In case the distance is doubted, frozen sections are
used to investigate resection margins intraoperatively. However, this method is
only usable to identify positive margins and clarifies little about the margin
distance. The low sampling rate results in a low sensitivity in predicting
close or positive margins.

A relatively new method to determine margin distance is intraoral resection
with a small Ultrasound (US)-probe. US is already used to determine
tumor-thickness in tongue cancer preoperatively, because of its high predictive
value. Four previous clinical studies applied US during tongue cancer
resections with favorable results. Interim analysis of our pilot study showed
that ultrasound (US)-guided tongue cancer resections resulted in 55% free
margins and reduction of the need for local adjuvant treatment (10%
re-resection and 10% irradiation). To apply this technique in standard clinical
care, it should be validated that intraoperative US-guided tongue cancer
resection improves local control and that it reduces the need for adjuvant
treatment, especially additional (chemo)irradiation. Additionally, it must be
validated that US-guided resections leads to more quality of life, more
head-and neck function and a better cost-efficiency than conventional surgery

A randomized controlled trial of 75 patients in both arms (150 in total). 75
patients will receive US-guided resections (treatment group), while other
patients will receive conventional treatment. Patients will receive
questionnaires (GRIX, SHI, SWAL-QOL (all centres) and EORTC - QLQ C30, EORTC
QLQ HN35, E5D5L (only UMC Utrecht, Haaglanden MC, UMC Groningen, Erasmus MC and
Medisch Spectrum Twente) this will take place one time before surgery and three
times (3, 6 and 12 months) after surgery. Additionally, with the same timing,
functional tests according to FROG (Functional Rehabilitation Outcome Grade)
will be taken, however this will be only conducted in het UMC Utrecht.

At the included patients at the participating centers that allready assess the
questionnaires EORTC QLQ30, EORTC H&N35, EQ5D5L as a clinical standard (i.e.
Rijnstate, Radboud and AVL), will be informed that the data from these
questionnaires will be used for the multiTRUSt study.

US-guided resections of tongue cancer.

US is a non-invasive imaging method without harmfull effects.
Usage of US might result in more resection of healthy tongue tissue. However,
there is a high potential on more free margins.
Time under narcosis will be elongated by 5-10 minutes.
Filling in questionnaires might be cognitively/emotionally exhausting for some
patients.
Testing patients on head-and neck function might be physically exhausting.