跳至主要内容
临床试验/NCT05412849
NCT05412849招募中不适用

Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?

Lund University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Complications related to dose, time and position of radiotherapy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Complications related to dose, time and position of radiotherapy

时间窗: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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