Radiation-induced Toxicity of the Heart
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Imaging and biomarkers.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer, Esophageal Cancer, Breast Cancer Female. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantitative Assessment of Radiation-induced Toxicity of the Heart
Overview
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 test Imaging and biomarkers
MR imaging of the heart, ECG and TTE measurements, blood sample
Primary outcome measures
- Cumulative cardio-toxicity after 1 or 5 years [Time frame: 12 or 60 months after end of treatment]
Secondary outcome measures (1)
- Cumulative cardio-toxicity (early and late) [Time frame: 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University of Technology, University Hospital Carl Gustav Carus, Department of Radiation T — Dresden
Identifiers
NCT: NCT06986291 · STR-CorTox-2024