Radiation Field, Dose and Fractionation Related to Mandibular Complications

NCT ID: NCT05412849

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Neoplasms Osteoradionecrosis Radiotherapy; Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiotherapy

Radiotherapy site, time perspective and dose

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Bengtsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Locations

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Skane University Hospital

Lund, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Philip Fransson, Msc

Role: CONTACT

0046 761077255

Facility Contacts

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Philip Fransson, Msc

Role: primary

0046 (0)761077255

Other Identifiers

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LundUH

Identifier Type: -

Identifier Source: org_study_id

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