Skip to content

A comparison of accelerated hypofractionated radiotherapy versus standard hypofractionated radiotherapy in early-stage breast cancer: a randomized controlled trial

A comparison of accelerated hypofractionated radiotherapy versus standard hypofractionated radiotherapy in early-stage breast cancer: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210403001
Enrollment
384
Registered
2021-04-03
Start date
2021-04-05
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Early stage breast cancer post breast conserving surgery Breast cancer Hypofractionation Radiation

Interventions

42.5 Gy in 16 fractions with boost 10 Gy in 4 fractions,40 Gy in 10 fractions
Standard hypofractionated radiotherapy,Accelerated hypofractionated radiotherapy

Sponsors

Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women age > 18 years 2. Early-stage invasive breast cancer (T1-2, N0, M0) and Ductal Carcinoma In Situ 3. Post breast conserving surgery with negative surgical margins 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion criteria

Exclusion criteria: 1. Received previous breast irradiation 2. Received breast reconstruction 3. Received neoadjuvant therapy 4. Bilateral breast cancer 5. Other malignancy before diagnosis which can interfere the treatment outcome 6. Hereditary breast cancer 7. Active connective tissue disease 8. Pregnancy or lactation 9. Unable or unwilling to give inform consent

Design outcomes

Primary

MeasureTime frame
local recurrence at 3 years and 5 years after end of the intervention Imaging and biopsy proved

Secondary

MeasureTime frame
Toxicity Acute toxicity: 1 and 3 months after complete treatment , late toxicity: 6 months after complete treatment The RTOG Acute radiation scoring criteria and the ROTG/EORTC late radiation Morbidity Scoring Scheme

Countries

Thailand

Contacts

Public ContactKanjana Shotelersuk

Division of Radiation Oncology, Radiology department, Faculty of Medicine, Chulalongkorn University

kanjanash@yahoo.co.th0896998008

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026