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临床试验/NCT03931356
NCT03931356已完成不适用

Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
diffusion capacity

研究概览

简要总结

assess the consequences of low doses of radiation delivered by the volumetric radiotherapy, on the respiratory capacity of patients treated for bronchopulmonary carcinoma, by a follow up of functional respiratory exploration.

详细描述

Radiation therapy with or without chemotherapy is a stable treatment in the management of patients with localized smack cell bronchopulmonary cancers, or not to small cells not metastatic but not operable. Radiation therapy results in changes in respiratory function, as measured by respiratory function tests and represented primarily by spirometry, total body plethysmography, and the diffusion capacity of the alveolar-capillary membrane.

Although these tests are minimally invasive, few studies have investigated the implications of radiation therapy on lung function in patients treated for pulmonary neoplasia, while these patients are often already carriers of respiratory diseases and will receive further chemotherapy during their illness, subject to their general good condition, including respiratory. No method has been recognized as superior for measuring the consequences of radiation therapy on respiratory function. After chest radiotherapy alone, the decline in diffusion capacity is estimated at 10-34%. New irradiation techniques have emerged over the last decade, in particular dynamic arc therapy. This innovative technology, combined with image-guided irradiation processes, ensures high-precision, short-term treatment, but exposes virtually all of the lungs to irradiation, although at very low doses, the objective consequences of which on respiratory functional explorations have never been reported.

The aim of this study is therefore to assess the consequences of low doses of radiation delivered by this recent technology, volumetric therapy, on the respiratory capacity of patients treated with radiotherapy within the framework of of bronchopulmonary carcinoma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • age >18 years
  • bronchopulmonary carcinoma histological proved
  • indication of radio(chimio)therapy alone approved by multidisciplinary comitee
  • non opposition formular completed

排除标准

  • SBRT indication
  • history of thoracic surgery or irradiation
  • unstable disease
  • oxygenotherapy dependance
  • severe chronic bronchitis
  • collagen disease
  • pregnancy
  • contraception refusal
  • refusal or incapacity to participate

结局指标

主要结局

diffusion capacity

时间窗: 3 months

diminution of 20% or more of the diffusion capacity at 3 months

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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