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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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 15, 2022
Est. primary completion date September 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 years - bronchopulmonary carcinoma histological proved - OMS 0-2 - indication of radio(chimio)therapy alone approved by multidisciplinary comitee - non opposition formular completed Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary function tests
analysis of lung volume and diffusion capacity

Locations

Country Name City State
France CHRU de Brest (Morvan) Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary diffusion capacity diminution of 20% or more of the diffusion capacity at 3 months 3 months
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