Cardiopulmonary Toxicity of Thoracic Radiotherapy

Recruiting now

Conditions studied: Oesophageal Cancer, Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03978377

Run by

University Medical Center Groningen

People needed

320

Starts

2018-09-01

Expected to finish

2027-04-01

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Radboud UMC — Nijmegen, Gelderland, Netherlands (enrolling)
• Universitaire Ziekenhuizen Leuven — Leuven, Belgium
• NHS Greater Glasgow and Clyde — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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