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Clinical Trial NCT04452032 (StomRay) for Head and Neck Squamous Cell Carcinoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer (StomRay) Phase 2 40

Active, not recruiting
Clinical Trial NCT04452032 (StomRay) is designed to study Prevention for Head and Neck Squamous Cell Carcinoma. It is a Phase 2 interventional study that is active, not recruiting, having started on November 17, 2020, with plans to enroll 40 participants. Led by Jules Bordet Institute, it is expected to complete by May 16, 2027. The latest data from ClinicalTrials.gov was last updated on November 8, 2024.
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,...Show More
Official Title

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

Conditions
Head and Neck Squamous Cell Carcinoma
Other Study IDs
  • StomRay
  • IJB-RT-HNC-002
NCT ID Number
NCT04452032
Start Date (Actual)
2020-11-17
Last Update Posted
2024-11-08
Completion Date (Estimated)
2027-05-16
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle arm
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...Show More
Dental avulsion
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 t...Show More
Radiotherapy
Radiotherapy: All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Risk of dental complication
Frequency of dental fractures according to the teeth radiotherapy delivered dose
At 36 months after end of radiotherapy
Risk of dental complication
Frequency of dental caries according to the parotid radiotherapy delivered dose
At 36 months after end of radiotherapy
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy according to the location of the tumour
At 36 months after end of radiotherapy
Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy according to the TNM stage
At 36 months after end of radiotherapy
Validation of a "predictive dose model" of radiotherapy
Predictive dose of radiotherapy with the real dose of radiotherapy received
At 36 months after end of radiotherapy
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental caries per patient
At 36 months after end of radiotherapy
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental fractures per patient
At 36 months after end of radiotherapy
Comparison of the predictive dose of radiotherapy with the dental complication probability
Number of dental avulsions per patient
At 36 months after end of radiotherapy
Assessment of Quality of life
Avulsion-free
At 36 months after end of radiotherapy
Assessment of Quality of life
Number of patients who developp an osteoradionecrosis of the jaw
At 36 months after end of radiotherapy
Assessment of Quality of life
Outcome measure: completion of xerostomia questionnaire
At 36 months after end of radiotherapy
Assessment of Quality of life
Outcome measure: completion of EORTC: QLQ-C30 questionnaire
At 36 months after end of radiotherapy
Assessment of Quality of life
Outcome measure: completion of EORTC: QLQ-H\&N43 questionnaire
At 36 months after end of radiotherapy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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
Jules Bordet Institute logoJules Bordet Institute
No contact data.
3 Study Locations in 1 Countries
CHU saint Pierre, Brussels, 1000, Belgium
Hôpital Erasme, Brussels, 1070, Belgium
Institut Jules Bordet, Brussels, 1070, Belgium