SMC Radiation Oncology Breast Cancer Cohort Study

NCT ID: NCT05775757

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Radiotherapy Side Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Hypofractionated 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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Breast cancer treated with curative surgery

Exclusion Criteria

* History of thoracic radiation therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Haeyoung Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haeyoung Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Haeyoung Kim, MD, PhD

Role: CONTACT

82-2-3410-2612

Nalee Kim, MD, PhD

Role: CONTACT

82-2-3410-2612

Facility Contacts

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Haeyoung Kim, MD, PhD

Role: primary

82-2-3410-2612

Other Identifiers

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SMC 2021-05-045

Identifier Type: -

Identifier Source: org_study_id

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