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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:
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiation therapy | Radiation | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haeyoung Kim, MD, PhD | Contact | 82-2-3410-2612 | haeyoung0131.kim@samsung.com | |
| Nalee Kim, MD, PhD | Contact | 82-2-3410-2612 | rodr.naleekim@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haeyoung Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 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 |