- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03931356
Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer. (TEFRARC)
Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brest, France
- CHRU de Brest (Morvan)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diffusion capacity
Time Frame: 3 months
|
diminution of 20% or more of the diffusion capacity at 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29 BRC17.0167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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