Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03978377
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2019-02-01
Brief Title:
Cardiopulmonary Toxicity of Thoracic Radiotherapy
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Cardiopulmonary Toxicity of Thoracic Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLARIFY
Brief Summary:
Radiotherapy improves locoregional control and survival of thoracic tumour patients However the associated exposure of normal tissues often leads to side effects and possibly even reduces survival Indeed there is growing evidence that overall survival after radiotherapy for lung and oesophageal cancer is related to the radiation dose to heart and lungs This suggests that thoracic radiotherapy causes mortality which is currently not recognized as radiation-induced toxicity So the question arises how to explain this treatment-related mortality
Interestingly Ghobadi et al demonstrated in rats that thoracic irradiation can lead to pulmonary hypertension PH Histopathological analysis showed that radiation-induced PH closely resembles the pulmonary arterial hypertension PAH subtype Moreover in a clinical pilot study we confirmed early signs of PH including dose-dependent reductions in blood flow towards the lungs in radiotherapy patients
In general PH significantly affects survival Moreover the PAH subtype is the most-rapidly progressive and lethal subtype However medical treatment can significantly slow down PAH progression providing opportunities for secondary prevention Yet hard evidence that radiation-induced PH is a clinically relevant phenomenon in patients treated for thoracic tumours is lacking
Interestingly Ghobadi et al demonstrated in rats that thoracic irradiation can lead to pulmonary hypertension PH Histopathological analysis showed that radiation-induced PH closely resembles the pulmonary arterial hypertension PAH subtype Moreover in a clinical pilot study we confirmed early signs of PH including dose-dependent reductions in blood flow towards the lungs in radiotherapy patients
In general PH significantly affects survival Moreover the PAH subtype is the most-rapidly progressive and lethal subtype However medical treatment can significantly slow down PAH progression providing opportunities for secondary prevention Yet hard evidence that radiation-induced PH is a clinically relevant phenomenon in patients treated for thoracic tumours is lacking
Detailed Description:
In the present study the incidence and time course of treatment-related changes in cardio-pulmonary physiology will be assessed using standard diagnostic tools such as echocardiography cardiac MRI CMR and serum biomarkers and relate them to the radiation dose distribution Such insight in the characteristics of this possible radiation-induced PH and contributing risk factors is essential to develop primary radiation dose optimization prevention strategies
The general objective of this study is to test the hypothesis that pulmonary hypertension PH is a clinically relevant radiation-induced side effect of thoracic irradiation If confirmed this allows us to take appropriate measures in patient care to improve quality of life in thoracic cancer patients
To investigate this hypothesis the following specific aims have been defined
To assess the incidence and time course of PH in a prospective cohort study in patients treated with radiotherapy for lung or oesophageal cancer
To characterize other changes in myocardial function and pulmonary arteries and their function using cardiac MR
To determine treatment-related risk factors in particular radiation dose factors to the lungs and heart that could be used for future optimization strategies to minimize the risk of inducing PH in these patients
To determine the clinical impact by correlating PH to patient-rated outcome measure PROMs and survival Taken together this study will determine if radiation-induced pulmonary hypertension is a clinically relevant toxicity and will provide information required for future studies on its prevention and treatment In addition more insight will be obtained on other forms of cardiovascular damage and complications that may occur in these patients
The general objective of this study is to test the hypothesis that pulmonary hypertension PH is a clinically relevant radiation-induced side effect of thoracic irradiation If confirmed this allows us to take appropriate measures in patient care to improve quality of life in thoracic cancer patients
To investigate this hypothesis the following specific aims have been defined
To assess the incidence and time course of PH in a prospective cohort study in patients treated with radiotherapy for lung or oesophageal cancer
To characterize other changes in myocardial function and pulmonary arteries and their function using cardiac MR
To determine treatment-related risk factors in particular radiation dose factors to the lungs and heart that could be used for future optimization strategies to minimize the risk of inducing PH in these patients
To determine the clinical impact by correlating PH to patient-rated outcome measure PROMs and survival Taken together this study will determine if radiation-induced pulmonary hypertension is a clinically relevant toxicity and will provide information required for future studies on its prevention and treatment In addition more insight will be obtained on other forms of cardiovascular damage and complications that may occur in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None