Non metastatic breast cancer Ultrahypofraction Proton radiotherapy Non metastatic breast cancer Acute skin toxicity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Female who pathologically proven breast cancer and undergone surgery (mastectomy and breast conservation surgery). Aged at least 21 year old ECOG 0-2 Stage 1-3 (according to AJCC 8th edition)
Exclusion criteria
Exclusion criteria: Prior radiotherapy to ipsilateral breast/thorax/chest wall Any radiotherapy for currently diagnosed breast cancer prior to randomization Any active skin problem on chest wall and axillary area or connective tissue disease Other non malignant system disease that would prevent patients from receiving study treatment or required follow up including pregnancy or lactating Surgical margin positive Bilateral breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute skin toxicity Within 3 months Common Toxicity Criteria Adverse Event version 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic outcome Within 3 months Four points Harvard/National Surgical Adjuvant Breast and Bowel Project/Radiation Therapy Oncology Group cosmetic criteria scale and four point likert-type scales,Locoregional recurrence and distant metastasis 2 years The National Comprehensive Cancer Network version 6.2020,Late toxicity 1 year Common Toxicity Criteria Adverse Event version 5 | — |
Countries
Thailand
Contacts
Research affairs, faculty of medicine, Chulalongkorn university