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Late side effects in radio(chemo)therapy [R(CH)T] pose a critical limitation to patients' overall survival and quality of life. Even though toxicities of the heart are highly relevant for patients with cancer in the thoracic region, risk stratification models for these toxicities are lacking. In this study, liquid, functional and imaging biomarkers are being investigated for their use in prediction of cardiac toxicity following R(CH)T for patients with thoracic malignancies.
79 patients with non-small cell lung or esophageal cancer, and 246 patients with breast cancer to be treated with curative R(CH)T at the University Hospital Carl Gustav Carus Dresden, Germany will be included in this investigation. Dosimetric parameters from the applied radiation treatment plans, magnetic-resonance-imaging, electrocardiography, transthoracic echocardiography as well as blood-biomarkers will be collected to determine their predictive power against the primary endpoint of cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events [CTCAE] v 5.0) 3-5 years after R(CH)T.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Other | Patients with non-small cell lung or esophageal cancer (cohort 1) or with breat cancer (cohort 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging and biomarkers | Diagnostic Test | MR imaging of the heart, ECG and TTE measurements, blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative cardio-toxicity after 1 or 5 years | Cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events [CTCAE] v 5.0) 1 years after R(CH)T in patients with non-small cell lung or esophageal cancer or 5 years after R(CH)T in patients with breast cancer | 12 or 60 months after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative cardio-toxicity (early and late) | Cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events [CTCAE] v 5.0) 3 months as well as 2, 3, 4 or 5 years after R(CH)T and in addition 10 years after R(CH)T in patients with breast cancer only. | 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients with breast cancer (cohort 2)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther G. C. Troost, Prof. Dr. med. Dr. | Contact | +49 351 458 2238 | esther.troost@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Esther G. C. Troost, Prof. Dr. med. Dr. | Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology | Dresden | Germany | 01304 | Germany |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| D001943 | Breast Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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There are two cohorts (patients with non-small cell lung or esophageal cancer; patients with breast cancer) but receiving the same intervention.
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |