Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03931356 |
| Other study ID # |
29 BRC17.0167 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2019 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
University Hospital, Brest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
