Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy

Study Overview
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Brief Summary
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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%.

Official Title
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A Study Investigating How to Avoid Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy to Improve Survival, Funded by Yorkshire Cancer Research

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Blood tests & cardiac imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Blood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG) | Diagnostic Test: Blood tests & cardiac imaging<br>* Blood tests (full blood count, lipids, cholesterol, high sensitivity Troponin levels, C-reactive protein (CRP) and brain natriuretic peptide) Cardiac imaging - cardiac CT, cardiac ultrasound, 12-lead ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of radiation dose to the heart assessed using blood test (full blood count) | 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) | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels) | 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) | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using blood test (troponin) | 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) | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using blood test (C-reactive protein) | 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) | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide) | 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) | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound) | 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. | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT) | 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. | 4 months (duration of each participant on study) | 
| The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG) | 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. | 4 months (duration of each participant on study) |