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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COLA 1: Locally advanced non-small-cell lung cancer | 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. |
| |
| COLA 2 Locally advanced non-small-cell lung cancer | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiotherapy | Other | Cardiac Magnetic Resonance scan and ECG |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced non-small-cell lung cancer will be included at the department of oncology at Odense University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agon AO Olloni, MD | Contact | 42206617 | agon.olloni@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tine Schytte, Professor | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense C | 5000 | Denmark |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D008175 | Lung Neoplasms |
| D011832 | Radiation Injuries |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| 2 years |
| LVESV changes | Left ventricular endsystolic change in cMR | 2 years |
| LV mass in gram | Left ventricular mass in gram. | 2 years |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |