Clinical trial NCT03568981: Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
Official title: Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing radiotherapy after breast-conservating surgery at an academic center

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of patient reported psychosocial functioning score
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
measure: Change of patient reported psychosocial functioning score
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
measure: Change of patient reported patient treatment satisfaction score
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
measure: Change of patient reported patient treatment satisfaction score
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
measure: Change of patient reported physical functioning score
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
measure: Change of patient reported physical functioning score
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
measure: Change of patient reported body image score
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
measure: Change of patient reported body image score
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
measure: Change of breast cosmesis measures (excellent/good/poor)
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy
measure: Change of breast cosmesis measures (excellent/good/poor)
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
measure: Change of breast-tissue fibrosis measures (gram)
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy
measure: Change of breast-tissue fibrosis measures (gram)
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
Secondary outcomes:
measure: Incidence of Radiotherapy-related complications
timeFrame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
measure: Incidence of Radiotherapy-related complications
timeFrame: 2 year after radiotherapy (allowed to plus 8 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Korea
Study officials:
References: