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
The investigators want to:
- Assess whether curative radiotherapy for lung cancer leads to permanently reduced lung function
- To assess the predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy
- 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|
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.
- 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.
- 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.
- TLCO (gas diffusion capacity CO): Determination of the amount of oxygen that reaches to diffuse from the alveoli into the blood.
- Static lung volume TLC (total lung capacity) maximum lung volume after maximal inspiration. Measured using body plethysmography.
- 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|
|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|
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
- permanently reduced lung function [ Time Frame: 2 years ]
- predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy [ Time Frame: 2 years ]
- predictive value of genetic markers for permanently reduced lung function after curative radiotherapy [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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
|Contact: Janna Berg, MDfirstname.lastname@example.org|
|Contact: Åslaug Helland, Ph.D.||email@example.com|
|Vestfold Hospital Trust||Recruiting|
|Tønsberg, Norway, 3103|
|Contact: Janna Berg 4792835703 firstname.lastname@example.org|
|Contact: Åslaug Helland, PhD email@example.com|