Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Radiotherapy, Head and Neck cancer
Brief summary
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.
Detailed description
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.
Interventions
OTHEROptimisation of dental implant sites protection from irradiation
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
Sponsors
Hôpitaux Universitaires de Strasbourg
Institut de cancérologie Strasbourg Europe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be ≥ 18 years old * Performance Status 0 to 2 * Histologically-confirmed diagnosis of : infiltrating squamous cell carcinoma of the oral cavity or oropharynx * Indication for an exclusive radiotherapy or post-surgery radiotherapy, with or without chemotherapy * Indication for a radiotherapy of lymph node areas * Partial or complete toothlessness requiring rehabilitation * Signed informed consent from the patient
Exclusion criteria
* History of head and neck radiotherapy * Partial mandibulectomy * Retarded wound healing or trismus impairing radiological guide preparation * Patient refusing the study * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected | At baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retarded toxicity evaluation | 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | according to CTCAE v5.0 criteria |
| Quality of life assessed by the 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 | Score based on 30 items from EORTC QLQ-C30 questionnaire |
| Acute toxicity evaluation | every weeks during radiotherapy | according to CTCAE v5.0 criteria |
| Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire | At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | Score based on 14 items from OHIP-14 questionnaire |
| Implant survival rate | at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | Number of implant failure (Albrektsson modified criteria) |
| Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module | At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | Score based on 35 items from EORTC QLQ-H&N35 questionnaire |
Countries
France
Outcome results
None listed