Echocardiography for RILI Prediction

Maastricht Radiation Oncology15 enrolled

Overview

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value \<0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Study Type

OBSERVATIONAL

Enrollment

Conditions

NSCLC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion * Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability * WHO performance status 0-2 * No history of prior chest radiotherapy * No uncontrolled infectious disease * No other active malignancy * No prior lung surgery (VATS, wedge resection, segment resection, lobectomy) * Willing and able to comply with the study prescriptions * 18 years or older * Ability to give and having given written informed consent before patient registration Exclusion Criteria: * malignant pleural/pericardial effusion * history of prior chest radiotherapy * uncontrolled infectious disease * other active malignancy * prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

Locations (2)

MAASTRO clinic

Maastricht, Limburg, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0

Time frame: up to 3 months

Secondary Outcomes

Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0

Time frame: up to 6 months

Changes in dyspnea score after radiotherapy, compared to baseline

Time frame: up to 12 months

Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)

Time frame: up to 3 months

Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

Time frame: up to 3 months

Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.

Time frame: up to 3 months

Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image

Time frame: up to 6 months

Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea

Time frame: up to 12 months

Changes in physical activity levels and sedentary behavior, assessed by accelerometry

Time frame: up to 12 months

Pulmonary function based on spirometry

Time frame: up to 3 months

Data from ClinicalTrials.gov

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