Oral cavity cancer, Osteoradionecrosis
Conditions
Interventions
None listed
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: - Receiving postoperative external beam radiotherapy with curative intent at the Dept of Radiotherapy at Erasmus MC (including treatment after a locoregional recurrence and/or chemoradiotherapy). - Written informed consent. - Patient 18 years or older.
Exclusion criteria
Exclusion criteria: - Patients with RT of the neck region III-V only (for instance after lymph node recurrence) - Patients who are treated simultaneously for other tumors outside the oral cavity. - Patients who previously were treated with radiotherapy in the head & neck region. - Patients with a Karnofsky Performance Status <70 - Patients with limited fluency in Dutch (inadequate to comprehend the questionnaires).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of osteoradionecrosis and the development of associated complaints over time including early signs of osteoradionecrosis after postoperative radiotherapy for oral cavity cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in quality of life and oral functioning (as measured in EORTC QLQ C30, H&N 35, Eq5D, and EAT-10) - the development of trismus, graded over time according to CTCAE 5.0 and mouth opening - the development of xerostomia, graded over time according to CTCAE 5.0 and measurements in H&N35 - the development of dysphagia, graded over time according to CTCAE 5.0 and measurements in H&N 35 & EAT-10 - the development of self-reported main symptoms of ORN (as measured in MYMOP) over time. | — |
Contacts
Public ContactMichelle Möring
Erasmus MC
Outcome results
None listed