Clinical trial NCT03931356: Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.
Official title: Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Lung
Radiotherapy; Complications
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with bronchopulmonary carcinoma treated by radio(chimio)therapy alone

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: diffusion capacity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest (Morvan)
Study officials:
References: