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NCT Number: NCT06986291

Radiation-induced Toxicity of the Heart

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.

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Key information

Conditions

Non-small Cell Lung Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Drug-Related Side Effects and Adverse Reactions Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Heart Diseases Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology

Dresden, Germany, 01304

Location contact

Esther G. C. Troost, Prof. Dr. med. Dr.

CONTACT

[email protected]

+49 351 458 2238

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging and biomarkers

Diagnostic Test

MR imaging of the heart, ECG and TTE measurements, blood sample

Primary outcomes

  1. Cumulative cardio-toxicity after 1 or 5 years

    Time frame: 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 outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther G. C. Troost, Prof. Dr. med. Dr.

CONTACT

[email protected]

+49 351 458 2238

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Quantitative Assessment of Radiation-induced Toxicity of the Heart

Acronym: CorTox

Important dates

Study start
2025
Primary completion
2034
Study completion
2039
First posted
May 23, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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