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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568981
• Other study ID #: 4-2018-0160
• Status: Recruiting
• Start date: April 11, 2018
• Est. completion date: April 11, 2023

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: Yong Bae Kim, MD, PhD
• Phone: 82-2228-8095
• Email: ybkim3[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Partial 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.
• Whole 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of patient reported psychosocial functioning score	Patient reported psychosocial functioning measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Primary	Change of patient reported psychosocial functioning score	Patient reported psychosocial functioning measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Primary	Change of patient reported patient treatment satisfaction score	Patient reported patient treatment satisfaction measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Primary	Change of patient reported patient treatment satisfaction score	Patient reported patient treatment satisfaction measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Primary	Change of patient reported physical functioning score	Patient reported physical functioning measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Primary	Change of patient reported physical functioning score	Patient reported physical functioning measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Primary	Change of patient reported body image score	Patient reported body image score measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Primary	Change of patient reported body image score	Patient reported body image score measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Primary	Change of breast cosmesis measures (excellent/good/poor)	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.	Before radiotherapy (allowed to 8 weeks before radiotherapy
Primary	Change of breast cosmesis measures (excellent/good/poor)	breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software	2 year after radiotherapy (allowed to plus 8 weeks)
Primary	Change of breast-tissue fibrosis measures (gram)	breast-tissue fibrosis is measured by tissue compliance meter device.	Before radiotherapy (allowed to 8 weeks before radiotherapy
Primary	Change of breast-tissue fibrosis measures (gram)	breast-tissue fibrosis is measured by tissue compliance meter device.	2 year after radiotherapy (allowed to plus 8 weeks)
Secondary	Incidence of Radiotherapy-related complications	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.	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Secondary	Incidence of Radiotherapy-related complications	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.	2 year after radiotherapy (allowed to plus 8 weeks)