Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)

Patients Who Receive Thoracic Irradiation Clinical Trial

Official title:

A Prospective Cohort Study of Patients Receiving Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674501
• Other study ID #: 4-2020-1093
• Status: Recruiting
• Start date: December 22, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: Yonsei University
• Contact: Hong In Yoon
• Phone: 82-2-2228-8110
• Email: yhi0225[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the risk factors and mechanisms of cardiotoxicity following thoracic radiotherapy and to provide insights in preventing radiation-related cardiotoxicity.

-Condition or disease : Thoracic irradiation -Intervention/treatment : Cardiac evaluation, Blood sampling

Description:

Cancer patients who undergo thoracic irradiation receive a certain amount of dose to the heart. Cardiotoxicity may occur in some patients several years after radiotherapy due to the late effect of radiation. Considering that cardiotoxicity is often lethal, screening and preventing radiation-induced cardiotoxicity is crucial in patients receiving thoracic irradiation.

Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation. The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed. Among the patients who developed cardiotoxicity, blood sampling will be performed to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with solid cancer who are subject to thoracic irradiation.

2. Patients who are 20 years old or older

3. Eastern Cooperative Oncology Group Performance Status Scale 0-2

4. Patients with cognitive abilities to receive virtual reality information

Exclusion Criteria:

1. Patients with a history of previous thoracic irradiation

2. Patients who refused consent

3. Patients with a history of heart failure before radiotherapy

Related Conditions & MeSH terms

• Cardiotoxicity
• Patients Who Receive Thoracic Irradiation

Intervention

Procedure:
• Cardiac evaluation and blood sampling
Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation. The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed. The patients who developed cardiotoxicity will undergo blood sampling to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity rate		2 years
Secondary	Overall survival		2 years
Secondary	Cancer-specific survival		2 years
Secondary	Progression-free survival		2 years
Secondary	Other toxicity rates		2 years