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Recruiting NCT05775757

SMC Radiation Oncology Breast Cancer Cohort Study

— Observational Radiotherapy Side Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypofractionated radiation therapy.
Who it may be relevant to
Registry conditions: Radiotherapy Side Effect. Basic parameters: 18 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Change of cosmesis from baseline [Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)]
  • Change of cosmesis from baseline [Time frame: 2-3 weeks after the completion of radiation therapy]
  • Change of cosmesis from baseline [Time frame: 6 months after radiation therapy]
  • Change of cosmesis from baseline [Time frame: 1 year after radiation therapy]
  • Change of cosmesis from baseline [Time frame: 2 year after radiation therapy]
  • Change of cosmesis from baseline [Time frame: 5 year after radiation therapy]
  • Change of fibrosis from baseline [Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)]
  • Change of fibrosis from baseline [Time frame: 2-3 weeks after the completion of radiation therapy]
  • Change of fibrosis from baseline [Time frame: 6 months after radiation therapy]
  • Change of fibrosis from baseline [Time frame: 1 year after radiation therapy]

Eligibility criteria

Inclusion criteria

  • Breast cancer treated with curative surgery

Exclusion criteria

  • History of thoracic radiation therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT05775757 · SMC 2021-05-045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗