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BrUOG 351: PRE-OPERATIVE APBI USING NIBB

NCT03437915 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-09

No results posted yet for this study

Summary

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.

In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.

Conditions

Interventions

RADIATION

NIBB: accuboost

28.5 Gy delivered in 5 daily fractions

PROCEDURE

Partial mastectomy

4-12 weeks post NIBB

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Jaroslaw Hepel

    lead OTHER

Principal Investigators

  • Jaroslaw Hepel, MD · Rhode Island Hospital/ BrUOG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2020-01-21
Completion
2020-01-21

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Entities

Diseases

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 NCT03437915 on ClinicalTrials.gov