Cardiopulmonary toxicity of thoracic radiotherapy.

Cardiopulmonary toxicity of thoracic radiotherapy. - CLARIFY

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48574

Enrollment

240

Registered

2018-03-07

Start date

2018-09-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary toxicity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria: • Heart failure in the last 2 months • 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 MRIFor MRI part: • contra-indications for MRI

Design outcomes

Primary

Measure	Time frame
The following primary endpoints will be assessed: Primary aim is to confirm that PH occurs in patients receiving thoracic radiotherapy and assess incidence and time course. Therefore we decided to use high-risk pulmonary hypertension as assessed by echocardiography at one year after radiotherapy as primary endpoint. Following the ECS/ERS guidelines (25), a patient is classified as high risk of PH when meeting one of the following criteria: - tricuspid valve Doppler velocity 2.9-3.4m/s with other signs of PH (see below) - tricuspid valve Doppler velocity >3.4m/s Other signs of PH are: - Pulmonary artery acceleration time (2.2 m/s) - Doppler notching of right ventricular outflow tract signal (y) - Inferior Caval Vein collapsibility (>21 mm and 1.1 in systole) - RV dilatation (RVEDV>45mm)	—

Measure

Time frame

The following primary endpoints will be assessed: Primary aim is to confirm that PH occurs in patients receiving thoracic radiotherapy and assess incidence and time course. Therefore we decided to use high-risk pulmonary hypertension as assessed by echocardiography at one year after radiotherapy as primary endpoint. Following the ECS/ERS guidelines (25), a patient is classified as high risk of PH when meeting one of the following criteria: - tricuspid valve Doppler velocity 2.9-3.4m/s with other signs of PH (see below) - tricuspid valve Doppler velocity >3.4m/s Other signs of PH are: - Pulmonary artery acceleration time (2.2 m/s) - Doppler notching of right ventricular outflow tract signal (y) - Inferior Caval Vein collapsibility (>21 mm and 1.1 in systole) - RV dilatation (RVEDV>45mm)

—

Secondary

Measure	Time frame
The following secondary endpoints will be assessed: - Intermediate risk of PH: o tricuspid valve Doppler velocity	—

Countries

Netherlands

Outcome results