Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by: * adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues; * reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H\&N 35).
University Hospital Ghent
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
Reduction of acute and late treatment-induced dysphagia
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
Time frame: after 1 year
acute treatment-induced toxicity
Time frame: weekly during treatment
late treatment-induced toxicity
Time frame: after 1, 3, 6, 9 and 12 months
tumor response: imaging
Time frame: after 3 months
tumor response: clinical examination
Time frame: after 1, 3, 6, 9 and 12 months
local, regional and distant control: imaging
Time frame: after 3 months
local, regional and distant control: clinical examination
Time frame: after 1,3, 6, 9 and 12 months
local, regional and distant control: biopsy
Time frame: from 3 months on
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