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Trial Title:
SMC Radiation Oncology Breast Cancer Cohort Study
NCT ID:
NCT05775757
Condition:
Radiotherapy Side Effect
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated radiation therapy
Description:
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.
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
Criteria for eligibility:
Study pop:
Any breast cancer patients treated with curative surgery is eligible except for history
of thoracic radiation therapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Breast cancer treated with curative surgery
Exclusion Criteria:
- History of thoracic radiation therapy
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Haeyoung Kim, MD, PhD
Phone:
82-2-3410-2612
Email:
haeyoung0131.kim@samsung.com
Start date:
January 1, 2021
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775757
