Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
Recruiting
NCT Number: NCT05775757
SMC Radiation Oncology Breast Cancer Cohort Study
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
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–85 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Breast cancer treated with curative surgery
Exclusion criteria
- History of thoracic radiation therapy
Treatment and study plan
Hypofractionated Radiation Therapy
RadiationBoth 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.
Primary outcomes
-
Change of cosmesis from baseline
Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Evaluated by two blinded independent physicians based on photographs
-
Change of cosmesis from baseline
Time frame: 2-3 weeks after the completion of radiation therapy
Evaluated by two blinded independent physicians based on photographs
-
Change of cosmesis from baseline
Time frame: 6 months after radiation therapy
Evaluated by two blinded independent physicians based on photographs
-
Change of cosmesis from baseline
Time frame: 1 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
-
Change of cosmesis from baseline
Time frame: 2 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
-
Change of cosmesis from baseline
Time frame: 5 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
-
Change of fibrosis from baseline
Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Evaluated using fibrometer measuring both breast
-
Change of fibrosis from baseline
Time frame: 2-3 weeks after the completion of radiation therapy
Evaluated using fibrometer measuring both breast
-
Change of fibrosis from baseline
Time frame: 6 months after radiation therapy
Evaluated using fibrometer measuring both breast
-
Change of fibrosis from baseline
Time frame: 1 year after radiation therapy
Evaluated using fibrometer measuring both breast
-
Change of fibrosis from baseline
Time frame: 2 year after radiation therapy
Evaluated using fibrometer measuring both breast
-
Change of fibrosis from baseline
Time frame: 5 year after radiation therapy
Evaluated using fibrometer measuring both breast
-
Change of patient-reported outcome from baseline
Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Change of patient-reported outcome from baseline
Time frame: 2-3 weeks after the completion of radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Change of patient-reported outcome from baseline
Time frame: 6 months after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Change of patient-reported outcome from baseline
Time frame: 1 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Change of patient-reported outcome from baseline
Time frame: 2 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Change of patient-reported outcome from baseline
Time frame: 5 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
-
Physician assessed toxicity
Time frame: After 2-3 weeks after the start of radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
-
Physician assessed toxicity
Time frame: 2-3 weeks after the completion of radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
-
Physician assessed toxicity
Time frame: 6 months after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
-
Physician assessed toxicity
Time frame: 1 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
-
Physician assessed toxicity
Time frame: 2 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
-
Physician assessed toxicity
Time frame: 5 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Study contacts
Contact information is provided by the study sponsor or research team.
Haeyoung Kim, MD, PhD
CONTACT
Nalee Kim, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Samsung Medical Center
Other
Registry information
Official study title
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
Acronym: RASCO
Important dates
- Study start
- 2021
- Primary completion
- 2025
- Study completion
- 2030
- First posted
- Mar 20, 2023
- Registry last updated
- Jun 29, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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