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

NCT03645317 | Unknown

• 1 other identifier: M401
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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%.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (1)

Single arm

OTHER

Blood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG)

Diagnostic Test: Blood tests & cardiac imaging

Interventions

Blood tests & cardiac imaging DIAGNOSTIC_TEST

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof Corinne Faivre-Finn: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• University of Manchester: collaborator
• University of Leeds: collaborator
• Manchester University NHS Foundation Trust: collaborator

Study Sites (2)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Corinne Faivre-Finn, PhD

  The Christie NHS Foundation Trust / Univerrsity of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne Faivre-Finn, PhD

CONTACT

0044 (0)161 446 8200; corinne.finn@christie.nhs.uk

Elizabeth Craven, MSc

CONTACT

0161 446 3045; elizabeth.craven@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of thoracic radiation oncology

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 24, 2018
• Study Start: June 12, 2019
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)