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Intraoperative Radiotherapy for Korean Patients With Breast Cancer

NCT02213991 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2018-02-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.

Conditions

Interventions

DEVICE

Intraoperative radiotherapy using Intrabeam®

Operation day 1. Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. 2. Purse string suture pulles up tissues and wraps up the applicator. 3. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed. 4. After IORT, applicator was out of the operative field, and usual wound closure will be done. * Postoperative period * Chemotherapy WBRT (46 Gy) for 4\~5 weeks * Endocrine therapy or target therapy

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Joon Jeong, M.D. Ph.D. · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-10-31
Completion
2020-03-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT02213991 on ClinicalTrials.gov