Breast Cancer
Conditions
Brief summary
This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.
Interventions
RADIATIONPartial breast irradiation
After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.
RADIATIONWhole breast irradiation
After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS) * Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation * Good performance status (ECOG 0-1)
Exclusion criteria
* Recurrent breast cancer * History of ipsilateral breast irradiation * Positive resection margin status after breast surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of patient reported psychosocial functioning score | Before radiotherapy (allowed to 8 weeks before radiotherapy) | Patient reported psychosocial functioning measured in 7 point Likert scale |
| Change of patient reported patient treatment satisfaction score | Before radiotherapy (allowed to 8 weeks before radiotherapy) | Patient reported patient treatment satisfaction measured in 7 point Likert scale |
| Change of patient reported physical functioning score | Before radiotherapy (allowed to 8 weeks before radiotherapy) | Patient reported physical functioning measured in 7 point Likert scale |
| Change of patient reported body image score | Before radiotherapy (allowed to 8 weeks before radiotherapy) | Patient reported body image score measured in 7 point Likert scale |
| Change of breast cosmesis measures (excellent/good/poor) | Before radiotherapy (allowed to 8 weeks before radiotherapy | breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software \- Investigators will whether there are any changes on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis after radiotherapy. Any differences of theses parameters according to the radiotherapy techniques (PBI vs. WBI) will be examed. |
| Change of breast-tissue fibrosis measures (gram) | Before radiotherapy (allowed to 8 weeks before radiotherapy | breast-tissue fibrosis is measured by tissue compliance meter device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiotherapy-related complications | Before radiotherapy (allowed to 8 weeks before radiotherapy) | Investigators will check whether there are any kinds of radiotherapy-related complications after PBI or WBI. Any differences of complications according to the radiotherapy techniques will be examed. |
Countries
South Korea
Contacts
Primary ContactYong Bae Kim, MD, PhD
Outcome results
None listed