Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy
- Conditions
- Lung Cancer
- Interventions
- Diagnostic Test: Blood tests & cardiac imaging
- Registration Number
- NCT03645317
- Lead Sponsor
- Prof Corinne Faivre-Finn
- Brief Summary
Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) suitable for curative-intent radiotherapy
- Patients suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy > 4 months
- Age ≥ 18 years
- Patient has read and understood the participant information sheet and given informed consent
Exclusion criteria:
- No histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) and not suitable for curative-intent radiotherapy
- Patients not suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy < 4 months
- Age < 18 years
- Patient has not read and understood the participant information sheet and has not given informed consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Blood tests & cardiac imaging Blood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG)
- Primary Outcome Measures
Name Time Method The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using lipid \& cholesterol (LDL \& HDL) measurements at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using brain natriuretic peptide measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using cardiac CT scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac CT scan measured during the study: coronary calcium score (Agaston/Volume) - CAC-RDS 0, CAC-RDS 1, CAC-RDS 2, CAC-RDS 3, CAC-RADS classification.
The effect of radiation dose to the heart assessed using blood test (troponin) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using troponin measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (C-reactive protein) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using C-reactive protein measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using 12-lead ECG at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the ECG measured during the study: heart rate, rhythm, P wave, QRS complex, QT interval, ST segment \& PR interval.
The effect of radiation dose to the heart assessed using blood test (full blood count) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using full blood count measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound) 4 months (duration of each participant on study) The effect of radiation dose to the heart assessed using cardiac ultrasound scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac ultrasound measured during the study: parasternal long axis, parasternal short axis, apical 2/4/5 chambers, apical long axis, subcostal and parasternal notch.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom