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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time 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 |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all of the previous eligibility criteria.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU saint Pierre | Brussels | 1000 | Belgium | |||
| Hôpital Erasme |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Radiotherapy | Radiation | Radiotherapy: All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT). |
|
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 |
| Brussels |
| 1070 |
| Belgium |
| Institut Jules Bordet | Brussels | 1070 | Belgium |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |