SMC Radiation Oncology Breast Cancer Cohort Study (RASCO)

Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

• Changes in breast skin
• Factors related to breast skin changes
• Patient-reported outcomes
• Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

• Photographs
• Fibrometer
• Questionnaires (BREAST-Q)
• CTCAE version 4.03 evaluated by treating physicians

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Hypofractionated radiation therapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Haeyoung Kim, MD, PhD; Phone Number: 82-2-3410-2612; Email: haeyoung0131.kim@samsung.com
• Study Contact Backup: Name: Nalee Kim, MD, PhD; Phone Number: 82-2-3410-2612; Email: rodr.naleekim@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Haeyoung Kim, MD, PhD; Phone Number: 82-2-3410-2612; Email: haeyoung0131.kim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.

Description

Inclusion Criteria:

• Breast cancer treated with curative surgery

Exclusion Criteria:

• History of thoracic radiation therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	2-3 weeks after the completion of radiation therapy
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	6 months after radiation therapy
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	1 year after radiation therapy
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	2 year after radiation therapy
Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	5 year after radiation therapy
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	2-3 weeks after the completion of radiation therapy
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	6 months after radiation therapy
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	1 year after radiation therapy
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	2 year after radiation therapy
Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	5 year after radiation therapy
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	2-3 weeks after the completion of radiation therapy
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	6 months after radiation therapy
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	1 year after radiation therapy
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	2 year after radiation therapy
Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	5 year after radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	After 2-3 weeks after the start of radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	2-3 weeks after the completion of radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	6 months after radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	1 year after radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	2 year after radiation therapy
Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	5 year after radiation therapy

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Haeyoung Kim, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SMC 2021-05-045

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