Primary Non-operated Squamous Cell Carcinoma of Hypopharynx, Primary Non-operated Squamous Cell Carcinoma of Larynx, Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx
Conditions
Keywords
squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx
Brief summary
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.
Interventions
PROCEDUREvideo fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
PROCEDUREextra imaging
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.
OTHERscoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
OTHERscoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
OTHERscoring quality of life (QOL)
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).
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx. * Primary non-resected tumor and/or patients refused surgery * Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3 * Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven * Karnofsky performance status \>= 70 % * Age \>= 18 years old * Informed consent obtained, signed and dated before specific protocol procedures
Exclusion criteria
* Treatment combined with brachytherapy * Prior irradiation to the head and neck region * Surgery of the primary tumor except lymph node dissection prior to radiotherapy * induction chemotherapy * history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years * Distant metastases * Creatinine clearance (Cockroft-Gault) =\< 60 milliliter/minute before treatment or creatinine value \> 1,3 milligram/deciliter * Known allergy to the CT-contrast agents * Pregnant or lactating women * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of acute and late treatment-induced dysphagia | after 1 year | Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment. |
Secondary
| Measure | Time frame |
|---|---|
| late treatment-induced toxicity | after 1, 3, 6, 9 and 12 months |
| tumor response: imaging | after 3 months |
| tumor response: clinical examination | after 1, 3, 6, 9 and 12 months |
| acute treatment-induced toxicity | weekly during treatment |
| local, regional and distant control: clinical examination | after 1,3, 6, 9 and 12 months |
| local, regional and distant control: biopsy | from 3 months on |
| local, regional and distant control: imaging | after 3 months |
Countries
Belgium
Outcome results
None listed