Cardiopulmonary Toxicity of Thoracic Radiotherapy
Recruiting · NCT03978377 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Patients with oesophageal cancer in the mid or distal oesophagus and patients with NSCLC stage IIA-III or NSCLC stage IV with limited brain metastases (treatable with surgery or stereotactic radiosurgery) or SCLC limited disease (stage I-IIIB)
- Scheduled for external-beam radiotherapy with curative intention.
- WHO 0-2.
- Age \>= 18 years
- Written informed consent.
Exclusion criteria
- No heart failure in the last 2 months
- No pulmonary embolism in the last 2 months
- COPD gold IV
- BMI \>35
- History of thoracic radiotherapy
- Noncompliance with any of the inclusion criteria - For MRI part: Contra indications for MRI
- For MRI part:
- contra-indications for MRI
Where it is running
6 locations listed.
- NHS Greater Glasgow and Clyde - Glasgow, United Kingdom
- NHS Greater Glasgow and Clyde - Glasgow, United Kingdom
- Universitaire Ziekenhuizen Leuven - Leuven, Belgium
- Universitaire Ziekenhuizen Leuven - Leuven, Belgium
- Radboud UMC - Nijmegen, Gelderland, Netherlands
- Radboud UMC - Nijmegen, Gelderland, Netherlands