Radiotherapy Side EffectRASCONCT05775757
SMC Radiation Oncology Breast Cancer Cohort Study
An observational study of Radiotherapy Side Effect, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Radiotherapy Side Effect
- What is being tested?
- Hypofractionated radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.
Who may be able to join
- Breast cancer treated with curative surgery
Who cannot join
- History of thoracic radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Conditions
- Radiotherapy Side Effect
- Being tested
- Hypofractionated radiation therapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiation therapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Measured: 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
Measured: 2-3 weeks after the completion of radiation therapy
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Measured: 6 months after radiation therapy
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Measured: 1 year after radiation therapy
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Measured: 2 year after radiation therapy
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Measured: 5 year after radiation therapy
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: 2-3 weeks after the completion of radiation therapy
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: 6 months after radiation therapy
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: 1 year after radiation therapy
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: 2 year after radiation therapy
Change of fibrosis from baseline
Evaluated using fibrometer measuring both breast
Measured: 5 year after radiation therapy
Change of patient-reported outcome from baseline
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Measured: 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.
Measured: 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.
Measured: 6 months after radiation therapy
Change of patient-reported outcome from baseline
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Measured: 1 year after radiation therapy
Change of patient-reported outcome from baseline
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Measured: 2 year after radiation therapy
Change of patient-reported outcome from baseline
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Measured: 5 year after radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: After 2-3 weeks after the start of radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: 2-3 weeks after the completion of radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: 6 months after radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: 1 year after radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: 2 year after radiation therapy
Physician assessed toxicity
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Measured: 5 year after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haeyoung Kim, Samsung Medical Center
- Investigators
- Haeyoung Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775757
- Sponsor's protocol ID
- SMC 2021-05-045
- Acronym
- RASCO
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05775757
- Acronym / sponsor ID
- RASCO / SMC 2021-05-045
- Conditions
- Radiotherapy Side Effect
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.
Key inclusion criteria (1 listed)
- Breast cancer treated with curative surgery
Key exclusion criteria (1 listed)
- History of thoracic radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiation therapyBoth 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. | Radiation | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haeyoung Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cosmesis from baseline (time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.