Radiotherapy of Tongue Cancer Using an Intraoral Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2018-12-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tongue Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

N=6

Group Type EXPERIMENTAL

Intraoral stent

Intervention Type DEVICE

Radiotherapy with intraoral stent

Control group

N=7

Group Type ACTIVE_COMPARATOR

No intraoral stent

Intervention Type OTHER

Radiotherapy without intraoral stent

Interventions

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Intraoral stent

Radiotherapy with intraoral stent

Intervention Type DEVICE

No intraoral stent

Radiotherapy without intraoral stent

Intervention Type OTHER

Eligibility Criteria

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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