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Completed

NCT Number: NCT03931356

Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest (Morvan)

Brest, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Function Tests

Other

analysis of lung volume and diffusion capacity

Primary outcomes

  1. diffusion capacity

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: TEFRARC

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 30, 2019
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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