Skip to content

Acute skin toxicity and cosmesis outcome in ultrahypofractionated radiotherapy for non metastatic breast cancer treated with proton radiotherapy compared with photon radiotherapy

Acute skin toxicity and cosmesis outcome in ultrahypofractionated radiotherapy for non metastatic breast cancer treated with proton radiotherapy compared with photon radiotherapy

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210219004
Enrollment
140
Registered
2021-02-19
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non metastatic breast cancer Ultrahypofraction Proton radiotherapy Non metastatic breast cancer Acute skin toxicity

Interventions

Proton radiotherapy in ultrahypofraction dose,Photon radiotherapy in ultrahypofraction dose
Proton radiotherapy ,Photon radiotherapy

Sponsors

National research and innovation information system
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 99 Years

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

MeasureTime frame
Acute skin toxicity Within 3 months Common Toxicity Criteria Adverse Event version 5

Secondary

MeasureTime 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

Public ContactThanaporn Sarsitthithum

Research affairs, faculty of medicine, Chulalongkorn university

Thanapornsartoey@gmail.com0805844024

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026