TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

Sponsor
Universitätsmedizin Mannheim
Study ID
NCT01440010
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IORT with 20 Gy — RADIATION
    Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Study Details

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

Key Dates

Start date
Sep 1, 2011
Status verified
Dec 2025
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
1,133 participants (actual)

Arms

  • Arm: IORT with 50 kV x-rays, 20 Gy
    Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Primary Outcome Measure

Number of Patients With Local Recurrence [ Time Frame: 5 years ]

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