Radiation-induced Toxicity of the Heart

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer; Esophageal Cancer; Breast Cancer Female

• Registration Number: NCT06986291
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-29
• Study Start: 2025-08
• Primary Completion: 2034-12
• Study Completion: 2039-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 325

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; 🇩🇪 Dresden, Germany