A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
NCT06422403
Adenocarcinoma, Bronchial Neoplasms
Singapore
View Trial DetailsNCT Number: NCT03978377
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For MRI part:
Time frame: 1 year
High-risk pulmonary hypertension according to ESC/ERS classification
Time frame: 1 year
Change in Troponine T concentration, between baseline and at 1 year
Time frame: 1 year
Change in NTproBNP concentration, between baseline and at 1 year
Time frame: 1 year
Intermediate risk of pulmonary hypertension according to ESC/ERS classification
Time frame: 1 year
Cumulative incidence of other late cardiopulmonary toxicity, as classified by CTCAE4.0
Time frame: 1 year
PROMs (EORTC QoL C30), including five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting),
Time frame: 1 year
PROMs (EORTC QoL LC13), including lung cancer-associated symptoms (cough, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Contact information is provided by the study sponsor or research team.
CT Muijs, MD PhD
CONTACT
P van Luijk, DR
CONTACT
University Medical Center Groningen
Other
Acronym: CLARIFY
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