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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2022
Source Institut de cancérologie Strasbourg Europe
Contact Valérie SARTORI
Phone 368767223
Email v.sartori@icans.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Optimisation 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

Locations

Country Name City State
France Institut de cancérologie Strasbourg Europe Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe Hôpitaux Universitaires de Strasbourg

Country where clinical trial is conducted

France, 

Outcome

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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