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Clinical Trial Summary

The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.


Clinical Trial Description

Primary Objectives

To determine the 24-month complication rate of 25Gy in 5 fractions whole radiotherapy +/- concurrent boost as compared to 40Gy in 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event, 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor.

ARM 1: Conventional hypofractionation 40 Gy (RBE) / Gy in 15 daily fractions with optional 10 Gy (RBE) / Gy in 4 fractions sequential boost to a total dose of 50 Gy in 19 fractions; or a concomitant boost to total dose of 48Gy in 15 daily fractions.(n=41)

ARM 2: 5 Fraction Hypofractionation 25 Gy (RBE) / Gy in 5 daily fractions with optional concurrent boost to a total dose of 30 Gy (RBE) / Gy in 5 fractions (n=41) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03339934
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase N/A
Start date March 27, 2017
Completion date July 8, 2023

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