Squamous Cell Carcinoma of Head and Neck Clinical Trial
— OPPIDOMOfficial title:
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)
NCT number | NCT04801472 |
Other study ID # | 2020-013 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2021 |
Est. completion date | October 31, 2023 |
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.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut de cancérologie Strasbourg Europe | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Institut de cancérologie Strasbourg Europe | Hôpitaux Universitaires de Strasbourg |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Acute toxicity evaluation | according to CTCAE v5.0 criteria | every weeks during radiotherapy | |
Secondary | Retarded toxicity evaluation | according to CTCAE v5.0 criteria | 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Implant survival rate | Number of implant failure (Albrektsson modified criteria) | at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy |
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