SMC Radiation Oncology Breast Cancer Cohort Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05775757

Acronym

RASCO

Enrollment

500

Registered

2023-03-20

Start date

2021-01-01

Completion date

2030-12-31

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy Side Effect

Brief summary

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

Interventions

RADIATIONHypofractionated radiation therapy

Both 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Breast cancer treated with curative surgery

Exclusion criteria

* History of thoracic radiation therapy

Design outcomes

Primary

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

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORHaeyoung Kim, MD, PhD

Samsung Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026