4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer. (TEFRARC)

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. diffusion capacity [ Time Frame: 3 months ]
    diminution of 20% or more of the diffusion capacity at 3 months


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 26, 2019
First Posted Date April 30, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date January 14, 2019
Estimated Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2019) 		diffusion capacity [ Time Frame: 3 months ]
diminution of 20% or more of the diffusion capacity at 3 months
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patient with bronchopulmonary carcinoma treated by radio(chimio)therapy alone
Condition
  • Cancer, Lung
  • Radiotherapy; Complications
Intervention Other: Pulmonary function tests
analysis of lung volume and diffusion capacity
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 26, 2019) 		39
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 14, 2021
Estimated Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ulrike SHICK 02 98 22 33 98 ulrike.schick@chu-brest.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03931356
Other Study ID Numbers 2018-A02487-48
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Brest
Verification Date July 2019

治疗医院

新药特效药

治疗案例

前沿医讯