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

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

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

Study Overview

• Status: Unknown
• Conditions: Patients Who Receive Thoracic Irradiation
• Intervention / Treatment: Procedure: Cardiac evaluation and 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
    • Contact: Hong In Yoon; Phone Number: 82-2-2228-8110; Email: yhi0225@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with solid tumors who receive thoracic irradiation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Thoracic irradiation; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiotoxicity rate	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	2 years
Progression-free survival	2 years
Cancer-specific survival	2 years
Other toxicity rates	2 years

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Hong In Yoon, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 4-2020-1093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No