Echocardiography for RILI Prediction

NCT ID: NCT02501707

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2019-09-12

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.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role: collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk De Ruysscher, PhD.

Role: PRINCIPAL_INVESTIGATOR

MAASTRO-clinic (senior researcher)

Bas Kietselaer, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

AzM/MUMC (cardiologist)

Judith van Loon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

MAASTRO-clinic (radiation oncologist)

Philippe Lambin, Prof,MD,Phd

Role: PRINCIPAL_INVESTIGATOR

MAASTRO-clinic (radiation oncologist)

Anne-Marie Dingemans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MAASTRO-clinic (pulmonogist)

Locations

MAASTRO clinic

Maastricht, Limburg, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

echocardiographyRILI

Identifier Type: -

Identifier Source: org_study_id