Investigating heart and lung effects of radiotherapy in cancer patients
Cardiopulmonary Toxicity of Thoracic Radiotherapy
This study is trying to see if radiation treatment for esophageal cancer and lung cancer can cause high blood pressure in the lungs and how it affects patients' hearts and lungs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Leuven and 2 other locations) |
| Trial ID | NCT03978377 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence and progression of pulmonary hypertension (PH) as a potential side effect of thoracic radiotherapy in patients with oesophageal cancer and non-small cell lung cancer (NSCLC). Using diagnostic tools such as echocardiography, cardiac MRI, and serum biomarkers, the study will relate these physiological changes to the radiation dose received by the heart and lungs. The goal is to understand the characteristics of radiation-induced PH and identify risk factors to optimize treatment and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with mid or distal oesophageal cancer or stage IIA-III NSCLC scheduled for curative radiotherapy.
Not a fit: Patients with recent heart failure, pulmonary embolism, severe COPD, or those with a BMI over 35 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that minimize the risk of pulmonary hypertension in thoracic cancer patients, enhancing their quality of life.
How similar studies have performed: While there is emerging evidence linking thoracic radiotherapy to pulmonary hypertension, this specific investigation into its incidence and risk factors is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven and 2 other locations
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium (Terminated)
- Radboud UMC — Nijmegen, Gelderland, Netherlands (Recruiting)
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Terminated)
Study contacts
- Study coordinator: CT Muijs, MD PhD
- Email: c.t.muijs@umcg.nl
- Phone: 00315036115179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.