Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT03568981
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-05-15
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of patient reported psychosocial functioning score	2 year after radiotherapy (allowed to plus 8 weeks)	Patient reported psychosocial functioning measured in 7 point Likert scale
Change of patient reported patient treatment satisfaction score	2 year after radiotherapy (allowed to plus 8 weeks)	Patient reported patient treatment satisfaction measured in 7 point Likert scale
Change of patient reported physical functioning score	2 year after radiotherapy (allowed to plus 8 weeks)	Patient reported physical functioning measured in 7 point Likert scale
Change of patient reported body image score	2 year after radiotherapy (allowed to plus 8 weeks)	Patient reported body image score measured in 7 point Likert scale
Change of breast cosmesis measures (excellent/good/poor)	2 year after radiotherapy (allowed to plus 8 weeks)	breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software
Change of breast-tissue fibrosis measures (gram)	2 year after radiotherapy (allowed to plus 8 weeks)	breast-tissue fibrosis is measured by tissue compliance meter device.

Secondary Outcome Measures

Name	Time	Method
Incidence of Radiotherapy-related complications	2 year after radiotherapy (allowed to plus 8 weeks)	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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of