Lung Cancer
Conditions
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%.
Interventions
DIAGNOSTIC_TESTBlood tests & cardiac imaging
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
Sponsors
The Leeds Teaching Hospitals NHS Trust
University of Manchester
University of Leeds
Manchester University NHS Foundation Trust
Prof Corinne Faivre-Finn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 (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 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 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. |
| 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 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. |
Countries
United Kingdom
Contacts
Primary ContactCorinne Faivre-Finn, PhD
Backup ContactElizabeth Craven, MSc
Outcome results
None listed