Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy - Clinical Trial for Lung Cancer | NCT03645317

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Blood tests & cardiac imaging

About this trial

This is an interventional basic science trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Leeds Teaching Hospitals NHS Trust
The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

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)

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03645317

First Posted

July 20, 2018

Last Updated

July 27, 2021

Sponsor

Prof Corinne Faivre-Finn

Collaborators

The Leeds Teaching Hospitals NHS Trust, University of Manchester, University of Leeds, Manchester University NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03645317

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 12, 2019 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof Corinne Faivre-Finn

Collaborators

The Leeds Teaching Hospitals NHS Trust, University of Manchester, University of Leeds, Manchester University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Other

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Blood tests & cardiac imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

The effect of radiation dose to the heart assessed using blood test (full blood count)

Description

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)

Time Frame