Clinical trial NCT03645317: Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy
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
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: University of Manchester
name: University of Leeds
name: Manchester University NHS Foundation Trust
First posted: 2018-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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%.


Eligibility criteria: 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

Primary outcomes:
measure: The effect of radiation dose to the heart assessed using blood test (full blood count)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using blood test (troponin)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using blood test (C-reactive protein)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT)
timeFrame: 4 months (duration of each participant on study)
measure: The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG)
timeFrame: 4 months (duration of each participant on study)
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust / Univerrsity of Manchester
name: Corinne Faivre-Finn, PhD
role: PRINCIPAL_INVESTIGATOR
References: