Cardiopulmonary Toxicity of Thoracic Radiotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No heart failure in the last 2 months

No pulmonary embolism in the last 2 months

COPD gold IV

BMI >35

Trial population

This study focuses on two patient populations: 1) Patients with oesophageal cancer in the mid or distal oesophagus, who will be treated with radiotherapy with curative intent, with or without chemotherapy, with or without surgery. 2\) 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), who will be treated with radiotherapy with curative intent, with or without chemotherapy. Patients will be included in 3 participating centers: * University Medical Center Groningen, Groningen, The Netherlands * Beatson West of Scotland Cancer Centre /NHS Greater Glasgow and Clyde, Glasgow, United Kingdom * Radboud UMC, Nijmegen, The Netherlands

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of patients with high risk of pulmonary hypertension

High-risk pulmonary hypertension according to ESC/ERS classification

Time frame
1 year

Secondary outcomes

1

Troponine T change

Change in Troponine T concentration, between baseline and at 1 year

Time frame
1 year
2

NTproBNP change

Change in NTproBNP concentration, between baseline and at 1 year

Time frame
1 year
3

Number of patients with intermediate risk of pulmonary hypertension

Intermediate risk of pulmonary hypertension according to ESC/ERS classification

Time frame
1 year
4

Cumulative incidence of other late cardiopulmonary toxicity, as classified by CTCAE4.0

Cumulative incidence of other late cardiopulmonary toxicity, as classified by CTCAE4.0

Time frame
1 year

Other outcomes

Sponsors and contacts

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