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

Universitätsmedizin Mannheim

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: IORT with 20 Gy

Study type: Observational

Funder types: Other

Identifiers

NCT01440010

TARGIT BQR

Details and patient eligibility

About

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

Full description

Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = >1000 patients is planned.

Enrollment: 1,133 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tumor diameter < 3,5 cm
• Informed consent

Exclusion criteria

• No informed consent
• Tumor size > 3,5 cm
• No indication for a boost

Trial design

1,133 participants in 1 patient group

IORT with 50 kV x-rays, 20 Gy

Description:

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Treatment:

Radiation: IORT with 20 Gy