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

Phase 2

• Conditions: Early stage breast cancer post breast conserving surgery; Breast cancer; Hypofractionation; Radiation

• Registration Number: TCTR20210403001
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-03
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-06

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 384

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local recurrence at 3 years and 5 years after end of the intervention Imaging and biopsy proved

Secondary Outcome Measures

Name	Time	Method
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