Actively Recruiting

Age: 18Years +
All Genders
ID03978377

Cardiopulmonary Toxicity of Thoracic Radiotherapy in Lung and Oesophageal Cancer Patients

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

320

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the potential cardiopulmonary side effects of thoracic radiotherapy in patients with oesophageal cancer and non-small cell lung cancer. The study aims to determine if pulmonary hypertension (PH), particularly the pulmonary arterial hypertension subtype, is a clinically relevant radiation-induced side effect affecting survival and quality of life. This observational study seeks to clarify how radiation dose to the heart and lungs may contribute to treatment-related mortality, which is currently underrecognized. The study will assess changes in heart and lung function over time using diagnostic methods such as echocardiography, cardiac MRI, and blood biomarkers. Patients scheduled for curative external-beam radiotherapy will be monitored to track the incidence and progression of PH and other cardiovascular changes in relation to radiation dose. The research will also explore risk factors and the clinical impact of PH by correlating findings with patient-reported outcomes and survival. Participants will undergo regular assessments including imaging scans, blood tests, and quality of life questionnaires over at least one year. Researchers will measure the number of patients at high and intermediate risk for pulmonary hypertension, changes in cardiac biomarkers, and the incidence of other late cardiopulmonary toxicities. This comprehensive monitoring will help identify radiation-induced cardiovascular damage and inform future prevention and treatment strategies. The study is sponsored by University Medical Center Groningen and started in 2018 with an expected completion in 2027.

CONDITIONS

Brief Title

Cardiopulmonary Toxicity of Thoracic Radiotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with mid or distal oesophageal cancer, NSCLC stage IIA-III, NSCLC stage IV with limited brain metastases treatable by surgery or radiosurgery, or limited SCLC stage I-IIIB
  • Scheduled to receive external-beam radiotherapy with curative intent
  • WHO performance status of 0 to 2
  • Age 18 years or older
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • History of heart failure within the last 2 months
  • History of pulmonary embolism within the last 2 months
  • Chronic obstructive pulmonary disease classified as GOLD IV
  • Body mass index over 35
  • Previous thoracic radiotherapy
  • Contraindications for MRI (for participants in the MRI part of the study)
  • Failure to meet any inclusion criteria

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At baseline and during follow-up within 1 year

Participants undergo diagnostic assessments including echocardiography, cardiac MRI, and serum biomarker tests to evaluate cardiopulmonary physiology related to radiation treatment.

Multiple visits over 1 year for diagnostic tests

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored to assess the incidence and progression of pulmonary hypertension and other cardiopulmonary toxicities after thoracic radiotherapy.

Periodic follow-up visits over 1 year

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

P

P van Luijk, DR

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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