Non-small Cell Lung CancerCorToxNCT06986291
Radiation-induced Toxicity of the Heart
A study testing Imaging and biomarkers in people with Non-small Cell Lung Cancer and Esophageal Cancer, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Esophageal Cancer, Breast Cancer Female
- What is being tested?
- Imaging and biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2025to Dec 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Dresden, Germany, 01304
Esther G. C. Troost, Prof. Dr. med. Dr., +49 351 458 2238, str.studien@uniklinikum-dresden.de
About this study
Official title: Quantitative Assessment of 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.
Read the 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.
- Being tested
- Imaging and biomarkers
- Keywords
- Non-small cell lung cancer, Esophageal cancer, Breast cancer, Cardiotoxicity, Radio(chemo)therapy, MRI, Cardiac function test, Omics analyses
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging and biomarkersDiagnostic test
MR imaging of the heart, ECG and TTE measurements, blood sample
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Other | Patients with non-small cell lung or esophageal cancer (cohort 1) or with breat cancer (cohort 2) Receives: Diagnostic Test: Imaging and biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 or 60 months after end of treatment
Secondary outcomes (1)
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.
Measured: 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2034 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There are two cohorts (patients with non-small cell lung or esophageal cancer; patients with breast cancer) but receiving the same intervention.
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Esther Troost, Technische Universität Dresden
- Investigators
- Esther G. C. Troost, Prof. Dr. med. Dr., Principal investigator, Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986291
- Sponsor's protocol ID
- STR-CorTox-2024
- Acronym
- CorTox
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Radiation-induced Toxicity of the Heart
- ClinicalTrials.gov ID
- NCT06986291
- Acronym / sponsor ID
- CorTox / STR-CorTox-2024
- Keywords
- Non-small cell lung cancer, Esophageal cancer, Breast cancer, Cardiotoxicity, Radio(chemo)therapy, MRI, Cardiac function test, Omics analyses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are two cohorts (patients with non-small cell lung or esophageal cancer; patients with breast cancer) but receiving the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Other | Diagnostic Test: Imaging and biomarkersPatients with non-small cell lung or esophageal cancer (cohort 1) or with breat cancer (cohort 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging and biomarkersMR imaging of the heart, ECG and TTE measurements, blood sample | Diagnostic test | Diagnostic |
Primary outcome
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
1 secondary outcome
Cumulative cardio-toxicity (early and late)
Time frame: 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esther G. C. Troost, Prof. Dr. med. Dr. principal investigator
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging and biomarkers in people with Non-small Cell Lung Cancer and Esophageal Cancer, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther G. C. Troost, Prof. Dr. med. Dr. (+49 351 458 2238, esther.troost@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative cardio-toxicity after 1 or 5 years (time frame: 12 or 60 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.