Breast Cancer Female, Esophageal Cancer, Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Esophageal cancer, Breast cancer, Cardiotoxicity, Radio(chemo)therapy, MRI, Cardiac function test, Omics analyses
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTImaging and biomarkers
MR imaging of the heart, ECG and TTE measurements, blood sample
Sponsors
Technische Universität Dresden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There are two cohorts (patients with non-small cell lung or esophageal cancer; patients with breast cancer) but receiving the same intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years old or older * Patient's consent and written consent is available * Patients with the non-small cell lung cancer or esophageal cancer or breast cancer who have an indication for intended curative radio(chemo)therapy (in the case of breast cancer inclusion of female patients only)
Exclusion criteria
* Patients who are not capable of giving consent * Pregnant women * Patients with contraindications for MRI examinations (pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, permanent make-up, metal splinters or osseosynthetic implants) * Patients with insufficient kidney function (glomerular filtration rate (GFR) of less than 30 ml/min) * Patients with the aforementioned tumour entities for whom a palliative indication exists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative cardio-toxicity after 1 or 5 years | 12 or 60 months after end of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative cardio-toxicity (early and late) | 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment | 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. |
Countries
Germany
Contacts
Primary ContactEsther G. C. Troost, Prof. Dr. med. Dr.
Outcome results
None listed