CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 2,354 enrolled
Drug / intervention
Standard fractionation whole breast irradiation +3 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01349322
NCT01349322Phase 3Active
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A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer

Radiation Therapy Oncology Group·interventional·Posted May 6, 2011·Updated Mar 5, 2026

In Brief

A Phase 3 clinical trial evaluating Standard fractionation whole breast irradiation, Hypofractionated whole breast irradiation, and 2 other interventions for Breast Cancer. Active but no longer recruiting, targeting 2,354 participants across 415 sites in 8 countries.

Detailed Summary

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Hong Kong, Israel, Japan, Singapore, South Korea, Switzerland, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 3ActiveOverdue
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2011
Enrollment StartMay 24, 2011
Primary CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 15.2 years ago

Interventions

Standard fractionation whole breast irradiationradiation

Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 25 fractions of 2.0 Gy for a total dose of 50.0 Gy or 16 fractions of 2.67 Gy for a total dose of 42.7 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.

Hypofractionated whole breast irradiationradiation

Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 15 fractions of 2.67 Gy for a total dose of 40.0 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.

Concurrent boostradiation

15 fractions of 3.2 Gy for a total dose of 48 Gy to the lumpectomy cavity. Given concurrently with treatment to the entire breast. May be given by either electron beam or photon beams using either 3D-CRT or IMRT.

Sequential boostradiation

6 fractions of 2.0 Gy per fraction for a total dose of 12 Gy or 7 fractions of 2.0 Gy for a total dose of 14 Gy to the lumpectomy cavity. May be given by either electron beam or photon beams using either 3D-CRT or IMRT. Begins without a treatment break after completion of the treatment to the entire breast.