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Lung Function Changes After Curative Targeted Radiotherapy of Non-small-cell Lung Carcinoma

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ClinicalTrials.gov Identifier: NCT02428049
Recruitment Status : Unknown
Verified December 2015 by Janna Berg, Sykehuset i Vestfold HF.
Recruitment status was:  Recruiting
First Posted : April 28, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborators:
Norwegian Radium Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Janna Berg, Sykehuset i Vestfold HF

Brief Summary:

The investigators want to:

  1. Assess whether curative radiotherapy for lung cancer leads to permanently reduced lung function
  2. To assess the predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy
  3. To assess the predictive value of genetic markers for permanently reduced lung function after curative radiotherapy

Condition or disease Intervention/treatment
Lung Cancer Radiotherapy Lung Function Changes Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Detailed Description:

This prospective controlled study plan to include 70 patients with lung cancer who will be its own control group for changes in lung function, and 50 COPD patients who will take the same blood samples as the study group.

It will be included lung cancer patients in stages IA-IIIA destined to have stereotactic or conventional radiotherapy and chemotherapy in curative intent.

Lung function tests The following lung functions will be measured in the study. This is examinations being done routinely in patients with COPD and indicates the degree of respiratory depression in these patients.

  1. Vital capacity, FVC: Forced vital capacity - The total amount of air in liters a person manages to blow out after first having drawn breath as much as possible.
  2. FEV1 (forced expiratory volume first second): Forced expiratory volume during first second - Number of liters of air blown out in the first second, when the test subject blows out so hard he or she can.
  3. TLCO (gas diffusion capacity CO): Determination of the amount of oxygen that reaches to diffuse from the alveoli into the blood.
  4. Static lung volume TLC (total lung capacity) maximum lung volume after maximal inspiration. Measured using body plethysmography.
  5. Static lung volume RV (residual volume) is the volume of air remaining in the lungs after a maximal expiration. Measured using body plethysmography.

Other parameters that measures the effect and side effect of radiation therapy. Patients receiving radiation therapy are followed both clinically (the patients general condition) and radiological studies, to examine the state of illness and treatment effect.

Patients will be followed by radiology (X-ray and CT thorax), measurements of O2 saturation (SaO2 at rest), measurements of partial oxygen and carbon dioxide pressure (blood gas) and 6 min. walk test (measuring how many feet the patient was able to walk within 6 min., how tired he is, oxygen saturation).

Moreover, using a questionnaire where breathlessness will be graded according to the MMRC (Modified Medical Research Council Dyspnea Score's). It consists of 10 questions and concerns "last 7 days". Abratt et al. found in 1995 a worsening dyspnea score in patients who lost more than 10% diffusion capacity.

Part of the project is to take blood samples. Specific blood samples will be analyzed to identify biomarkers that could predict the development of radiation-induced lung changes. One can imagine that in the development of severe radiation fibrosis, there are also certain identifiable markers detectable in blood samples.


Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lung Function Changes After Curative Targeted Radiotherapy of Non-small-cell Lung Carcinoma
Study Start Date : October 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Lung cancer patients
Lung cancer patients in stages IA-IIIA destined to have stereotactic or conventional radiotherapy and chemotherapy in curative intent
Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent
Control group
COPD patients



Primary Outcome Measures :
  1. permanently reduced lung function [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy [ Time Frame: 2 years ]

Other Outcome Measures:
  1. predictive value of genetic markers for permanently reduced lung function after curative radiotherapy [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood samples


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:   Probability Sample
Study Population
lung cancer patients in stages IA-IIIA
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Current lung cancer, not older than 8 weeks
  • Received written consent
  • Non small cell lung cancer
  • Stage IA-IIIA
  • Inoperable

Exclusion Criteria:

  • Lack of consent
  • Operable
  • Additional cancer disease
  • Small cell lung carcinoma or neuroendocrine lung cancer

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): NCT02428049


Contacts
Contact: Janna Berg, MD 92835703 jannaberg1@gmail.com
Contact: Åslaug Helland, Ph.D. aslaug.helland@gmail.com

Locations
Norway
Vestfold Hospital Trust Recruiting
Tønsberg, Norway, 3103
Contact: Janna Berg    4792835703    jannaberg1@gmail.com   
Contact: Åslaug Helland, PhD       aslaug.helland@gmail.com   
Sponsors and Collaborators
Sykehuset i Vestfold HF
Norwegian Radium Hospital
Oslo University Hospital

Responsible Party: Janna Berg, consultant, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02428049     History of Changes
Other Study ID Numbers: 2013/169
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms