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NCT04228991 · ClinicalTrials.gov record · last posted 2026-06-17

Hypofractionated LocoRegional Radiotherapy in Breast Cancer

Study acronym: RHEAL
StatusActive, Not Recruiting
PhasePhase 3
Started2021-02-10
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.

Amendment record 36 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 36 times since 2020-01-10; most recent amendment 2026-06-15. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-07-29
Status change Recruiting→Active, Not Recruitingv34
2020-11-03
Status change Not Yet Recruiting→Recruitingv4
Trial Details
NCT Number NCT04228991
Lead Sponsor Ontario Clinical Oncology Group (OCOG)
Collaborators: Canadian Institutes of Health Research (CIHR), McMaster University
Conditions Breast Neoplasms, Radiotherapy, Lymphedema
Enrollment 588 participants
Start Date 2021-02-10
Primary Completion 2028-07 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-17