Radiotherapy of Tongue Cancer Using an Intraoral Stent
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About
Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.
Full description
Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate.
The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients with tongue cancer
- Curatively intended radiotherapy requiring a total dose of 50-70 Gy
- Age >18 years
- Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion criteria
None
Trial design
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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