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NCT Number: NCT04452032

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU saint Pierre, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental avulsion

Procedure

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.

Radiotherapy

Radiation

Radiotherapy:

All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT).

Primary outcomes

  1. Risk of dental complication

    Time frame: At 36 months after end of radiotherapy

    Frequency of dental fractures according to the teeth radiotherapy delivered dose

  2. Risk of dental complication

    Time frame: At 36 months after end of radiotherapy

    Frequency of dental caries according to the parotid radiotherapy delivered dose

Secondary outcomes

  1. Validation of a "predictive dose model" of radiotherapy

    Time frame: At 36 months after end of radiotherapy

    Predictive dose of radiotherapy according to the location of the tumour

  2. Validation of a "predictive dose model" of radiotherapy

    Time frame: At 36 months after end of radiotherapy

    Predictive dose of radiotherapy according to the TNM stage

  3. Validation of a "predictive dose model" of radiotherapy

    Time frame: At 36 months after end of radiotherapy

    Predictive dose of radiotherapy with the real dose of radiotherapy received

  4. Comparison of the predictive dose of radiotherapy with the dental complication probability

    Time frame: At 36 months after end of radiotherapy

    Number of dental caries per patient

  5. Comparison of the predictive dose of radiotherapy with the dental complication probability

    Time frame: At 36 months after end of radiotherapy

    Number of dental fractures per patient

  6. Comparison of the predictive dose of radiotherapy with the dental complication probability

    Time frame: At 36 months after end of radiotherapy

    Number of dental avulsions per patient

  7. Assessment of Quality of life

    Time frame: At 36 months after end of radiotherapy

    Avulsion-free

  8. Assessment of Quality of life

    Time frame: At 36 months after end of radiotherapy

    Number of patients who developp an osteoradionecrosis of the jaw

  9. Assessment of Quality of life

    Time frame: At 36 months after end of radiotherapy

    Outcome measure: completion of xerostomia questionnaire

  10. Assessment of Quality of life

    Time frame: At 36 months after end of radiotherapy

    Outcome measure: completion of EORTC: QLQ-C30 questionnaire

  11. Assessment of Quality of life

    Time frame: At 36 months after end of radiotherapy

    Outcome measure: completion of EORTC: QLQ-H&N43 questionnaire

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Acronym: StomRay

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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