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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard radiotherapy treatment | Active Comparator | These patients receive the normal standard treatment. |
|
| adaptive radiotherapy | Experimental | These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video fluoroscopy | Procedure | video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| acute treatment-induced toxicity | weekly during treatment | |
| late treatment-induced toxicity | after 1, 3, 6, 9 and 12 months | |
| tumor response: imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Neve, PhD, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium | |||
| University Hospital Leuven |
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| Label | URL |
|---|---|
| Related Info | View source |
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| extra imaging | Procedure | 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. |
|
| scoring acute toxicity | Other | Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2. |
|
| scoring of late toxicity | Other | Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale. |
|
| scoring quality of life (QOL) | Other | 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). |
|
| after 3 months |
| tumor response: clinical examination | after 1, 3, 6, 9 and 12 months |
| local, regional and distant control: imaging | after 3 months |
| 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 |
| Leuven |
| 3000 |
| Belgium |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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