Radiation Field, Dose and Fractionation Related to Mandibular Complications

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412849
• Other study ID #: LundUH
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: February 2022
• Source: Lund University Hospital
• Contact: Philip Fransson, Msc
• Phone: 0046 761077255
• Email: philip.fransson[@]skane.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2023
• Est. primary completion date: January 2023
• 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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Osteoradionecrosis
• Radiotherapy; Complications

Intervention

Radiation:
• Radiotherapy
Radiotherapy site, time perspective and dose

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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.