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

• Conditions: Patients Who Receive Thoracic Irradiation
• Interventions: Procedure: Cardiac evaluation and blood sampling

• Registration Number: NCT04674501
• Lead Sponsor: Yonsei University

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2020-12-22
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracic irradiation	Cardiac evaluation and blood sampling	A cohort of cancer patients who receive thoracic irradiation. Patients with any type of malignancy, such as lung cancer, breast cancer, esophageal cancer, or thymoma, are eligible as long as the patients undergo thoracic irradiation.

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity rate	2 years

Secondary Outcome Measures

Name	Time	Method
Cancer-specific survival	2 years
Overall survival	2 years
Progression-free survival	2 years
Other toxicity rates	2 years

Trial Locations

Locations (1)

Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of