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Hypofractionated LocoRegional Radiotherapy in Breast Cancer

NCT04228991 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2025-11-18

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms
  • Radiotherapy
  • Lymphedema

Interventions

RADIATION

Locoregional radiation treatment - Conventional fractionation

40 Gray in 15 daily fractions over 3 weeks

RADIATION

Locoregional radiation treatment - Hypofractionation

26 Gray in 5 daily fractions over 1 week

Sponsors & Collaborators

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Timothy Whelan, MD · Juravinski Cancer Centre, McMaster University, Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2028-07-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228991 on ClinicalTrials.gov