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Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer. (TEFRARC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931356
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment
Cancer, Lung Radiotherapy; Complications Other: Pulmonary function tests

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.

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Study Type : Observational
Estimated Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : January 14, 2021
Estimated Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. diffusion capacity [ Time Frame: 3 months ]
    diminution of 20% or more of the diffusion capacity at 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with bronchopulmonary carcinoma treated by radio(chimio)therapy alone
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931356


Contacts
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Contact: Ulrike SHICK 02 98 22 33 98 ulrike.schick@chu-brest.fr

Locations
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France
CHRU de Brest (Morvan) Recruiting
Brest, France
Contact: Ulrike SCHICK    02 98 22 33 98    ulrike.schick@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03931356    
Other Study ID Numbers: 2018-A02487-48
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases