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Head and Neck Squamous Cell CarcinomaPhase 2StomRayNCT04452032

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

A Phase 2 study testing Dental avulsion and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Jules Bordet Institute at 3 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Dental avulsion and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesBelgium
Study dates
17 Nov 2020to 16 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • CHU saint Pierre

    Brussels, 1000

  • Hôpital Erasme

    Brussels, 1070

  • Institut Jules Bordet

    Brussels, 1070

Other trials in Belgium

About this study

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.

Being tested
Dental avulsion, Radiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental avulsionProcedure or surgery

    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.

  • RadiotherapyRadiation

    Radiotherapy:

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

Study groups in NCT04452032
Study groupRoleWhat they receive
Single armExperimentalThe 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.
Receives: Procedure: Dental avulsion; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of dental complication

    Frequency of dental fractures according to the teeth radiotherapy delivered dose

    Measured: At 36 months after end of radiotherapy

  2. Risk of dental complication

    Frequency of dental caries according to the parotid radiotherapy delivered dose

    Measured: At 36 months after end of radiotherapy

Secondary outcomes (11)

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

    Predictive dose of radiotherapy according to the location of the tumour

    Measured: At 36 months after end of radiotherapy

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

    Predictive dose of radiotherapy according to the TNM stage

    Measured: At 36 months after end of radiotherapy

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

    Predictive dose of radiotherapy with the real dose of radiotherapy received

    Measured: At 36 months after end of radiotherapy

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

    Number of dental caries per patient

    Measured: At 36 months after end of radiotherapy

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

    Number of dental fractures per patient

    Measured: At 36 months after end of radiotherapy

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

    Number of dental avulsions per patient

    Measured: At 36 months after end of radiotherapy

  7. Assessment of Quality of life

    Avulsion-free

    Measured: At 36 months after end of radiotherapy

  8. Assessment of Quality of life

    Number of patients who developp an osteoradionecrosis of the jaw

    Measured: At 36 months after end of radiotherapy

  9. Assessment of Quality of life

    Outcome measure: completion of xerostomia questionnaire

    Measured: At 36 months after end of radiotherapy

  10. Assessment of Quality of life

    Outcome measure: completion of EORTC: QLQ-C30 questionnaire

    Measured: At 36 months after end of radiotherapy

  11. Assessment of Quality of life

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

    Measured: At 36 months after end of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start17 Nov 2020
  3. Primary completion16 May 2026 (estimated)
  4. Study completion16 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452032
Sponsor's protocol ID
IJB-RT-HNC-002
Acronym
StomRay
Status last verified
Nov 2024
First submitted
8 Jun 2020
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dental avulsion and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Jules Bordet Institute at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of dental complication (time frame: At 36 months after end of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04452032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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