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organisationnal reason
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| Name | Class |
|---|---|
| Hôpitaux Universitaires de Strasbourg | UNKNOWN |
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This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.
35 patients will be included in this study and will benefit from a dental consultation for dental rehabilitation plan elaboration and radiological guide confection. Two dosimetric computer-tomography scans, with or without radiological guide, will be conducted. Virtual dental implants will be visualised by the dental surgeon on scanner images (with or without radiologic guide). After volume delineation and dosimetry calculations, the optimal treatment plan will be validated. Patients will be followed throughout radiotherapy and during 18 months following the end of radiotherapy for evaluation of toxicity, quality of life and dental implant survival rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with oral cavity or oropharyngeal squamous cell carcinoma | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimisation of dental implant sites protection from irradiation | Other | Optimal treatment plan validation after two dosimetric computer-tomography scans (with or without radiological guide) and visualisation of virtual dental implants on scanner images. Evaluation of toxicity, quality of life and dental implant survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected | Condition of dental implant sites protection (i.e. with minimal implantation risk, Dmax < 40 Gy), without degrading the coverage of planned targeted volume (≥ 95% of volume receiving 95 % of prescribed dose) | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity evaluation | according to CTCAE v5.0 criteria | every weeks during radiotherapy |
| Retarded toxicity evaluation | according to CTCAE v5.0 criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de cancérologie Strasbourg Europe | Strasbourg | 67033 | France |
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| 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
| Quality of life assessed by the EORTC QLQ-C30 questionnaire | Score based on 30 items from EORTC QLQ-C30 questionnaire | At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
| Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module | Score based on 35 items from EORTC QLQ-H&N35 questionnaire | At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
| Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire | Score based on 14 items from OHIP-14 questionnaire | At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
| Implant survival rate | Number of implant failure (Albrektsson modified criteria) | at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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