NCT02213991

Intraoperative Radiotherapy for Korean Patients With Breast Cancer

A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Local toxicity checklist * Hematoma needing surgical evacuation * Seroma needing more than three aspirations * Skin breakdown or delayed wound healing * Any complication needing surgical intervention * Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other. * Any complication of RTOG toxicity grade more than 2

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-10-01
• Completion: 2020-03-01
• First posted: 2014-08-12
• Last updated: 2018-02-15

Locations

1 site across 1 country: South Korea