COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)

Study Overview
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Brief Summary
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Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.

Detailed Description
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Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.

Official Title
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The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR

Conditions
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Cardiac Toxicity, Lung Cancer Stage III, Lung Cancer Stage II, Radiation Toxicity, Cardiac Disease

Intervention / Treatment
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* Other: Chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Years Inoperable and histologically/cytologically verified NSCLC. Planned treatment with curative intent. Capable of completing study procedures ECG and Cardiac MR. Able of giving written and informed consent before study procedures are initiated. Exclusion Criteria: Vulnerable patients. Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated. Claustrophobia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COLA 1: Locally advanced non-small-cell lung cancer<br>Patients with locally advanced non-small-cell lung cancer treated with radiotherapy alone or in combination with chemotherapy with curative intent. Patients are included before initiation of the treatment. A Cardiac MR and ECG are performed at the beginning of the treatment, and at 6, 12, and 24 months after radiotherapy. | Other: Chemoradiotherapy<br>* Cardiac Magnetic Resonance scan and ECG<br>|
| COLA 2 Locally advanced non-small-cell lung cancer<br>Patients with locally advanced non-small-cell lung cancer treated with radiotherapy alone or in combination with chemotherapy with curative intent. Patients not included in COLA 1 cohort are offered one cardiac MR and ECG between 12-24 months after radiotherapy treatment. | Other: Chemoradiotherapy<br>* Cardiac Magnetic Resonance scan and ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | All cause mortality | 2 Years | 
| Change in Left Ventricular Ejection Fraction | Change from baseline, evaluated by cardiac MR | Baseline, at 6, 12 and 24 months. | 
| Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0. | Assesed by patient interview and review of medical record. | 2 years. | 
| Cardiovascular specific mortality | Assesed by patient interview and review of medical record | 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late enhacment | Evaluated by cardiac MR. | At Baseline, 6, 12 and 24 months. | 
| LVEDV changes | Left ventricular enddiastolic change in cMR | 2 years | 
| LVESV changes | Left ventricular endsystolic change in cMR | 2 years | 
| LV mass in gram | Left ventricular mass in gram. | 2 years |