Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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