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Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

NCT02276885 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2025-12-30

Study results available
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Summary

The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

Conditions

Interventions

RADIATION

PBI Radiotherapy 6 Gy

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days

RADIATION

PBI Radiotherapy 8 Gy

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day

Sponsors & Collaborators

Principal Investigators

  • Naamit Gerber, MD · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2023-12-07
Completion
2026-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02276885 on ClinicalTrials.gov