NCT03978377Recruiting
Cardiopulmonary Toxicity of Thoracic Radiotherapy
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 320 (estimated)
- First submitted
- 1 Feb 2019
- Start date
- 1 Sept 2018
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Pulmonary arterial hypertension, High blood pressure, Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT03978377
What you commit to
- Study type: Observational
- Planned participants: 320
- From 1 Sept 2018 to the primary completion date, 1 Apr 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- No heart failure in the last 2 months
- History of thoracic radiotherapy
Other
- No pulmonary embolism in the last 2 months
- COPD gold IV
- BMI \>35
- Noncompliance with any of the inclusion criteria - For MRI part: Contra indications for MRI
- For MRI part:
- contra-indications for MRI
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaire Ziekenhuizen Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Terminated |
| NHS Greater Glasgow and Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Terminated |
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.