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

Prof Corinne Faivre-Finn

Status: Unknown

Conditions: Lung Cancer

Treatments: Diagnostic Test: Blood tests & cardiac imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03645317

M401

Details and patient eligibility

About

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%.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Single arm

Other group

Description:

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

Treatment:

Diagnostic Test: Blood tests & cardiac imaging