MedTrace Logo

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

NCT05417516 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2026-05-22

No results posted yet for this study

Summary

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Conditions

  • Breast Neoplasm Female
  • Radiotherapy
  • Cosmetic Outcome

Interventions

RADIATION

Partial Breast Irradiation (PBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

RADIATION

Whole Breast Irradiation (WBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Sponsors & Collaborators

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Timothy Whelan, M.D. · Juravinski Cancer Centre and McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2029-11-30
Completion
2031-11-30

Countries

  • Australia
  • Canada

Study Locations

More Related Trials

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 NCT05417516 on ClinicalTrials.gov