Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.

NCT ID: NCT03931356

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2022-10-15

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.

Conditions

Cancer, Lung; Radiotherapy; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Pulmonary function tests

analysis of lung volume and diffusion capacity

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest (Morvan)

Brest, , France

Countries

France

Other Identifiers

29 BRC17.0167

Identifier Type: -

Identifier Source: org_study_id