NCT03978377 Cardiopulmonary Toxicity of Thoracic Radiotherapy
| NCT ID | NCT03978377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Oesophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2018-09-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2018-09-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03978377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03978377 currently recruiting?
Yes, NCT03978377 is actively recruiting participants. Contact the research team at c.t.muijs@umcg.nl for enrollment information.
Where is the NCT03978377 trial being conducted?
This trial is being conducted at Leuven, Belgium, Nijmegen, Netherlands, Glasgow, United Kingdom.
Who is sponsoring the NCT03978377 clinical trial?
NCT03978377 is sponsored by University Medical Center Groningen. The trial plans to enroll 320 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.