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

Lung Cancer Clinical Trial

— ACCOLADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03645317
• Other study ID #: M401
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: The Christie NHS Foundation Trust
• Contact: Corinne Faivre-Finn, PhD
• Phone: 0044 (0)161 446 8200
• Email: corinne.finn[@]christie.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Blood 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

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (5)

Lead Sponsor	Collaborator
Prof Corinne Faivre-Finn	Manchester University NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, University of Leeds, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)