Actively Recruiting

Age: 18Years +
All Genders
NCT03978377

Cardiopulmonary Toxicity of Thoracic Radiotherapy

Led by University Medical Center Groningen · Updated on 2025-03-25

320

Participants Needed

3

Research Sites

447 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Cardiopulmonary Toxicity of Thoracic Radiotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with oesophageal cancer in the mid or distal oesophagus or patients with non-small cell lung cancer (NSCLC) stage IIA-III or NSCLC stage IV with limited brain metastases treatable with surgery or stereotactic radiosurgery or small cell lung cancer (SCLC) limited disease (stage I-IIIB)
  • Scheduled for external-beam radiotherapy with curative intention
  • WHO performance status 0 to 2
  • Age 18 years or older
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Heart failure in the last 2 months
  • Pulmonary embolism in the last 2 months
  • Chronic obstructive pulmonary disease (COPD) GOLD stage IV
  • Body mass index (BMI) greater than 35
  • History of thoracic radiotherapy
  • Noncompliance with any of the inclusion criteria
  • Contraindications for MRI for the MRI part of the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Terminated

2

Radboud UMC

Nijmegen, Gelderland, Netherlands, 6525 GA

Actively Recruiting

3

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Terminated

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Research Team

C

CT Muijs, MD PhD

CONTACT

P

P van Luijk, DR

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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