At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 103 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at heart and lung side effects (called cardiopulmonary toxicity) caused by radiotherapy to the chest. It includes people with cancer of the oesophagus (the food pipe) or non small cell lung cancer. The sponsor is University Medical Center Groningen.
Who can take part
- Adults aged 18 or over
- Have oesophageal cancer in the middle or lower part of the oesophagus, or non small cell lung cancer at certain stages, or small cell lung cancer at limited stages
- Due to have external-beam radiotherapy (a type of cancer treatment using radiation) with the aim of a cure
- Are well enough to care for themselves most of the time (WHO performance status 0-2) — ask the trial team what this means
- Have given written informed consent (agreed in writing to take part)
Who may not be able to
- Heart failure in the last 2 months
- A blood clot in the lungs (pulmonary embolism) in the last 2 months
- Very severe chronic obstructive pulmonary disease (COPD, a lung disease) — GOLD stage IV
- Body mass index (BMI) over 35
- Have had radiotherapy to the chest before
- Do not meet any of the inclusion criteria
- For the MRI (scan) part: cannot have an MRI scan
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 320
- Started
- 2018-09-01
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for oesophageal cancer
- • Clinical study - 320 participants
- • Radiotherapy improves locoregional control and survival of thoracic tumour patients
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with oesophageal cancer
Where?
- • Glasgow - NHS Greater Glasgow and Clyde
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
In the present study, the incidence and time course of treatment-related changes in cardio-pulmonary physiology will be assessed using standard diagnostic tools such as echocardiography, cardiac MRI (CMR) and serum biomarkers and relate them to the radiation dose distribution. Such insight in the characteristics of this possible radiation-induced PH and contributing risk factors is essential to develop primary (radiation dose optimization) prevention strategies. The general objective of this study is to test the hypothesis that pulmonary hypertension (PH) is a clinically relevant radiation-induced side effect of thoracic irradiation. If confirmed this allows us to take appropriate measures in patient care to improve quality of life in thoracic cancer patients. To investigate this hypothesis, the following specific aims have been defined: * To assess the incidence and time course of PH in a prospective cohort study in patients treated with radiotherapy for lung or oesophageal cancer. * To characterize other changes in myocardial function and pulmonary arteries, and their function using cardiac MR. * To determine treatment-related risk factors, in particular radiation dose factors to the lungs and heart that could be used for future optimization strategies to minimize the risk of inducing PH in these patients. * To determine the clinical impact by correlating PH to patient-rated outcome measure (PROMs) and survival. Taken together this study will determine if radiation-induced pulmonary hypertension is a clinically relevant toxicity and will provide information required for future studies on its prevention and treatment. In addition, more insight will be obtained on other forms of cardiovascular damage and complications that may occur in these patients.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Scheduled for external-beam radiotherapy with curative intention.
- ✓WHO 0-2.
- ✓Age \>= 18 years
- ✓Written agreement to take part.
Who cannot take part
- ✗No heart failure in the last 2 months
- ✗No lung embolism in the last 2 months
- ✗COPD gold IV
- ✗BMI \>35
- ✗History of thoracic radiotherapy
See the full criteria
Where Is This Study? (1 UK site)
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
How to Get in Touch
CT Muijs, MD PhD
Sponsor contactCONTACT
P van Luijk, DR
Sponsor contactCONTACT