SMC Radiation Oncology Breast Cancer Cohort Study

Radiotherapy Side Effect Clinical Trial

— RASCO  

Official title:

Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775757
• Other study ID #: SMC 2021-05-045
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: Haeyoung Kim, MD, PhD
• Phone: 82-2-3410-2612
• Email: haeyoung0131.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

• Changes in breast skin

• Factors related to breast skin changes

• Patient-reported outcomes

• Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

• Photographs

• Fibrometer

• Questionnaires (BREAST-Q)

• CTCAE version 4.03 evaluated by treating physicians

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Breast cancer treated with curative surgery

Exclusion Criteria:

• History of thoracic radiation therapy

Related Conditions & MeSH terms

• Radiotherapy Side Effect

Intervention

Radiation:
• Hypofractionated radiation therapy
Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	2-3 weeks after the completion of radiation therapy
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	6 months after radiation therapy
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	1 year after radiation therapy
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	2 year after radiation therapy
Primary	Change of cosmesis from baseline	Evaluated by two blinded independent physicians based on photographs	5 year after radiation therapy
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	2-3 weeks after the completion of radiation therapy
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	6 months after radiation therapy
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	1 year after radiation therapy
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	2 year after radiation therapy
Primary	Change of fibrosis from baseline	Evaluated using fibrometer measuring both breast	5 year after radiation therapy
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	2-3 weeks after the completion of radiation therapy
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	6 months after radiation therapy
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	1 year after radiation therapy
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	2 year after radiation therapy
Primary	Change of patient-reported outcome from baseline	BREAST-Q questionnaire is used to evaluate patient-reported outcome.	5 year after radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	After 2-3 weeks after the start of radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	2-3 weeks after the completion of radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	6 months after radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	1 year after radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	2 year after radiation therapy
Primary	Physician assessed toxicity	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.	5 year after radiation therapy