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Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS)

ConditionLocally Advanced Lung Non-Small Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with NSCLC

Patients with locally advanced disease (Stage 3)

Patients treated with RT at Fondazione IRCCS Istituto Nazionale dei Tumori

Disqualifiers

Previous thoracic radiotherapy

Previous heart surgery

Trial population

The study population will include consecutive NSCLC patients with locally advanced disease treated with RT at Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy

A set of ultrasound parameters will be normalised to the individual patient value at the baseline. We will evaluate an acute reaction (end of RT) and a late reaction/recovery assessment at 9 months after RT

Time frame
Baseline - End RT - 9 months after RT completion

Secondary outcomes

1

Major adverse cardiac events post-RT

MACEs will be evaluated and recorded during patient FU as a no/yes variable

Time frame
Baseline - End RT - 9 months after RT completion
2

Increase in cardiac calcification after RT

Calcification will be assessed through automatic software able to detect calcifications in the heart based on CT scans. Values will be compared with the baseline

Time frame
Baseline - End RT - 9 months after RT completion

Other outcomes

1

Longitudinal variation of cardiopulmonary functional parameters

A set of parameters will be assessed through the use of a smartwatch device. Variation with time will be compared to identify risk factors associated to patterns in time evolution.

Time frame
Daily evaluations from baseline to 9 months of FU
2

Texture variation in the heart substructures

Quantitative image analysis will be performed on protocol CT scans to assess morphology and tissue composition

Time frame
Baseline - End RT - 9 months after RT completion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Politecnico di Milano

Collaborator

Source ClinicalTrials.gov
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