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Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer (StomRay)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Dental avulsion
Radiotherapy
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. ECOG performance status ≤2
  3. Female and Male
  4. Newly diagnosed, histologically or cytologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, larynx, hypopharynx or cavum)
  5. Results of previous pre-treatment imaging (PET-CT and cervicofacial MRI and/or CT/scan)
  6. Eligible for treatment based on (chemo-)radiotherapy (with or without a surgical treatment)
  7. Agree to wear, three times per week, fluoride dental splint after RT
  8. HPV/p 16 testing results available at the time of screening (only for subjects with oropharynx cancer)
  9. Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st radiotherapy treatment
  10. Women of childbearing potential must agree to use of one effective method of contraception prior study entry and during the course of the study.
  11. Completion of all necessary screening procedures within 30 days prior to 1st radiotherapy treatment.
  12. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
  13. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by the principal investigator upon screening

Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all of the previous eligibility criteria.

Exclusion Criteria:

  1. Subject having less than ten teeth on dental arch
  2. Life expectancy less than 12 months
  3. History of previous head and neck irradiation
  4. Prior or current treatment with bisphosphonates or denosumab
  5. Presence of too many metal artefacts on the RT simulation scan preventing precise teeth contouring
  6. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
  7. Pregnancy and/or lactating women
  8. Subjects with imperfect amelogenesis

Sites / Locations

  • CHU saint Pierre
  • Institut Jules Bordet
  • Hôpital Erasme

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

The first phase of the study will consist of an evaluation of the initial dental state of each subject based on stomatological examination, orthopantomogram, bitewing radiographs, evaluation of potential risks of caries and fractures. Dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment.Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as bitewing radiographs. Orthopantomogram will be done once a year. Periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.

Outcomes

Primary Outcome Measures

Risk of dental complication
Frequency of dental fractures according to the teeth radiotherapy delivered dose
Risk of dental complication
Frequency of dental caries according to the parotid radiotherapy delivered dose

Secondary Outcome Measures

Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy according to the location of the tumour
Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy according to the TNM stage
Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy with the real dose of radiotherapy received
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental caries per patient
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental fractures per patient
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental avulsions per patient
Assessment of Quality of life
Avulsion-free
Assessment of Quality of life
Number of patients who developp an osteoradionecrosis of the jaw
Assessment of Quality of life
Outcome measure: completion of xerostomia questionnaire
Assessment of Quality of life
Outcome measure: completion of EORTC: QLQ-C30 questionnaire
Assessment of Quality of life
Outcome measure: completion of EORTC: QLQ-H&N43 questionnaire

Full Information

First Posted
June 8, 2020
Last Updated
May 9, 2023
Sponsor
Jules Bordet Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04452032
Brief Title
Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer
Acronym
StomRay
Official Title
Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
May 16, 2026 (Anticipated)
Study Completion Date
May 16, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multi-centric, one arm phase II study. The first phase of the study will consist of an evaluation of the initial dental state of each subject based on a stomatological examination, an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all potential risks of caries and fractures. For all of subjects, a dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment. Our previously developed predictive model for dental dose in function of the localisation of tumour and suspect lymph nodes based on the stomatological examination and on the pre-treatment imaging. An estimation of the intensity-modulated radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the pre-RT dental status. A contouring of the teeth will be performed and the planned dose for each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25 Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as two bitewing radiographs. An orthopantomogram will be done once a year. Furthermore, periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
The first phase of the study will consist of an evaluation of the initial dental state of each subject based on stomatological examination, orthopantomogram, bitewing radiographs, evaluation of potential risks of caries and fractures. Dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment.Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as bitewing radiographs. Orthopantomogram will be done once a year. Periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.
Intervention Type
Procedure
Intervention Name(s)
Dental avulsion
Intervention Description
Before radiotherapy, each subject undergoes a dental evaluation and if it is necessary, dental avulsions if their long-term survival is compromised (see in section 6.1.2) and if they are located in an area at risk to receive more than 40 Gy, so to develop osteoradionecrosis of the jaw. The avulsions should be performed as far as possible from the start of radiotherapy (RT) namely at least 2 weeks before irradiation to allow mucosal healing.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy: All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT).
Primary Outcome Measure Information:
Title
Risk of dental complication
Description
Frequency of dental fractures according to the teeth radiotherapy delivered dose
Time Frame
At 36 months after end of radiotherapy
Title
Risk of dental complication
Description
Frequency of dental caries according to the parotid radiotherapy delivered dose
Time Frame
At 36 months after end of radiotherapy
Secondary Outcome Measure Information:
Title
Validation of a "predictive dose model" of radiotherapy
Description
Predictive dose of radiotherapy according to the location of the tumour
Time Frame
At 36 months after end of radiotherapy
Title
Validation of a "predictive dose model" of radiotherapy
Description
Predictive dose of radiotherapy according to the TNM stage
Time Frame
At 36 months after end of radiotherapy
Title
Validation of a "predictive dose model" of radiotherapy
Description
Predictive dose of radiotherapy with the real dose of radiotherapy received
Time Frame
At 36 months after end of radiotherapy
Title
Comparison of the predictive dose of radiotherapy with the dental complication probability
Description
Number of dental caries per patient
Time Frame
At 36 months after end of radiotherapy
Title
Comparison of the predictive dose of radiotherapy with the dental complication probability
Description
Number of dental fractures per patient
Time Frame
At 36 months after end of radiotherapy
Title
Comparison of the predictive dose of radiotherapy with the dental complication probability
Description
Number of dental avulsions per patient
Time Frame
At 36 months after end of radiotherapy
Title
Assessment of Quality of life
Description
Avulsion-free
Time Frame
At 36 months after end of radiotherapy
Title
Assessment of Quality of life
Description
Number of patients who developp an osteoradionecrosis of the jaw
Time Frame
At 36 months after end of radiotherapy
Title
Assessment of Quality of life
Description
Outcome measure: completion of xerostomia questionnaire
Time Frame
At 36 months after end of radiotherapy
Title
Assessment of Quality of life
Description
Outcome measure: completion of EORTC: QLQ-C30 questionnaire
Time Frame
At 36 months after end of radiotherapy
Title
Assessment of Quality of life
Description
Outcome measure: completion of EORTC: QLQ-H&N43 questionnaire
Time Frame
At 36 months after end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old ECOG performance status ≤2 Female and Male Newly diagnosed, histologically or cytologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, larynx, hypopharynx or cavum) Results of previous pre-treatment imaging (PET-CT and cervicofacial MRI and/or CT/scan) Eligible for treatment based on (chemo-)radiotherapy (with or without a surgical treatment) Agree to wear, three times per week, fluoride dental splint after RT HPV/p 16 testing results available at the time of screening (only for subjects with oropharynx cancer) Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st radiotherapy treatment Women of childbearing potential must agree to use of one effective method of contraception prior study entry and during the course of the study. Completion of all necessary screening procedures within 30 days prior to 1st radiotherapy treatment. Signed Informed Consent form (ICF) obtained prior to any study related procedure. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by the principal investigator upon screening Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all of the previous eligibility criteria. Exclusion Criteria: Subject having less than ten teeth on dental arch Life expectancy less than 12 months History of previous head and neck irradiation Prior or current treatment with bisphosphonates or denosumab Presence of too many metal artefacts on the RT simulation scan preventing precise teeth contouring Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study. Pregnancy and/or lactating women Subjects with imperfect amelogenesis
Facility Information:
Facility Name
CHU saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

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Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer

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