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Spots Global Cancer Trial Database for Echocardiography for RILI Prediction

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Trial Identification

Brief Title: Echocardiography for RILI Prediction

Official Title: The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.

Study ID: NCT02501707

Conditions

NSCLC

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

MAASTRO clinic, Maastricht, Limburg, Netherlands

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Contact Details

Name: Dirk De Ruysscher, PhD.

Affiliation: MAASTRO-clinic (senior researcher)

Role: PRINCIPAL_INVESTIGATOR

Name: Bas Kietselaer, MD,Phd

Affiliation: AzM/MUMC (cardiologist)

Role: PRINCIPAL_INVESTIGATOR

Name: Judith van Loon, MD,PhD

Affiliation: MAASTRO-clinic (radiation oncologist)

Role: PRINCIPAL_INVESTIGATOR

Name: Philippe Lambin, Prof,MD,Phd

Affiliation: MAASTRO-clinic (radiation oncologist)

Role: PRINCIPAL_INVESTIGATOR

Name: Anne-Marie Dingemans, MD, PhD

Affiliation: MAASTRO-clinic (pulmonogist)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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