Head and Neck Neoplasms Clinical Trial
Official title:
Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?
| NCT number | NCT05412849 |
| Other study ID # | LundUH |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2023 |
| Est. completion date | July 2025 |
Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation. Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion. The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | July 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Clinical diagnosis of the head and neck malignancy - Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery Exclusion criteria - less than 12 months follow up - Under 18 years of age |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Skane University Hospital | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complications related to dose, time and position of radiotherapy | Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed. | The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively. |
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