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

Phase 2

• Conditions: on metastatic breast cancer; Ultrahypofraction; Proton radiotherapy; Non metastatic breast cancer; Acute skin toxicity

• Registration Number: TCTR20210219004
• Lead Sponsor: ational research and innovation information system

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Study Completion: 2023-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: Female
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute skin toxicity Within 3 months Common Toxicity Criteria Adverse Event version 5

Secondary Outcome Measures

Name	Time	Method
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