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Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM) (OPPIDOM)

Primary Purpose

Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Optimisation of dental implant sites protection from irradiation

About this trial

This is an interventional other trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Radiotherapy, Head and Neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut de cancérologie Strasbourg EuropeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with oral cavity or oropharyngeal squamous cell carcinoma

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Acute toxicity evaluation

according to CTCAE v5.0 criteria

Retarded toxicity evaluation

according to CTCAE v5.0 criteria

Quality of life assessed by the EORTC QLQ-C30 questionnaire

Score based on 30 items from EORTC QLQ-C30 questionnaire

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

Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire

Score based on 14 items from OHIP-14 questionnaire

Implant survival rate

Number of implant failure (Albrektsson modified criteria)

Full Information

NCT ID

NCT04801472

First Posted

March 11, 2021

Last Updated

August 2, 2022

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

Hôpitaux Universitaires de Strasbourg

1. Study Identification

Unique Protocol Identification Number

NCT04801472

Brief 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)

Acronym

OPPIDOM

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 7, 2021 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

Hôpitaux Universitaires de Strasbourg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma

Keywords

Radiotherapy, Head and Neck cancer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with oral cavity or oropharyngeal squamous cell carcinoma

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Optimisation of dental implant sites protection from irradiation

Intervention Description

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

Primary Outcome Measure Information:

Title

Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected

Description

Time Frame

At baseline

Secondary Outcome Measure Information:

Title

Acute toxicity evaluation

Description

according to CTCAE v5.0 criteria

Time Frame

every weeks during radiotherapy

Title

Retarded toxicity evaluation

Description

according to CTCAE v5.0 criteria

Time Frame

3 months, 6 months, 12 months, 18 months after the end of radiotherapy

Title

Quality of life assessed by the EORTC QLQ-C30 questionnaire

Description

Score based on 30 items from EORTC QLQ-C30 questionnaire

Time Frame

At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy

Title

Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module

Description

Score based on 35 items from EORTC QLQ-H&N35 questionnaire

Time Frame

At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy

Title

Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire

Description

Score based on 14 items from OHIP-14 questionnaire

Time Frame

At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy

Title

Implant survival rate

Description

Number of implant failure (Albrektsson modified criteria)

Time Frame

at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valérie SARTORI

Phone

368767223

Ext

v.sartori@icans.eu

First Name & Middle Initial & Last Name or Official Title & Degree

Manon VOEGELIN, PhD

Phone

368767360

Ext

promotion-rc@icans.eu

Facility Information:

Facility Name

Institut de cancérologie Strasbourg Europe

City

Strasbourg

ZIP/Postal Code

67033

Country

France

Individual Site Status

Recruiting

Facility Contact: