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
• Interventions: Radiation: Partial breast irradiation; Radiation: Whole breast irradiation

• 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)

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Exclusion Criteria

• Recurrent breast cancer
• History of ipsilateral breast irradiation
• Positive resection margin status after breast surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Partial Breast Irradiation (PBI)	Partial breast irradiation	Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer
Whole Breast Irradiation (WBI)	Whole breast irradiation	Patients receiving whole breast irradiation for breast cancer

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