CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 412 enrolled
Drug / intervention
Daily Radiation Therapy +1 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/NCT01000662
NCT01000662Phase 3Completed
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Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost

NYU Langone Health·interventional·Posted Oct 23, 2009·Updated Aug 6, 2020

In Brief

A Phase 3 clinical trial evaluating Daily Radiation Therapy and Weekly Radiation Therapy for Breast Cancer. Completed, enrolled 412 participants across 3 sites.

Detailed Summary

All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2012
Study CompletionJun 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.7 years ago

Interventions

Daily Radiation Therapyradiation

15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.

Weekly Radiation Therapyradiation

15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.