Prospective monitoring of osteoradionecrosis after postoperative radiotherapy for oral cavity cancer.

• Conditions: Oral cavity cancer, Osteoradionecrosis

• Registration Number: NL-OMON29332
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

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

- 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).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Changes in quality of life and oral functioning (as measured in EORTC QLQ C30, H&N 35, Eq5D, and EAT-10) <br>- the development of trismus, graded over time according to CTCAE 5.0 and mouth opening <br>- the development of xerostomia, graded over time according to CTCAE 5.0 and measurements in H&N35 <br>- the development of dysphagia, graded over time according to CTCAE 5.0 and measurements in H&N 35 & EAT-10 <br>- the development of self-reported main symptoms of ORN (as measured in MYMOP) over time.