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

NCT01440010 | Completed Results

• 1 other identifier: TARGIT BQR
• Study Type: observational
• Target: 1,133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

IORT; Boost; Breast cancer; Local recurrence; Toxicity; LENT SOMA; TARGIT; Quality Control Registry

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Local Recurrence

  The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate

  5 years

Secondary Outcomes (1)

• Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost

  84 months

Study Arms (1)

IORT with 50 kV x-rays, 20 Gy

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

Radiation: IORT with 20 Gy

Interventions

IORT with 20 Gy RADIATION

Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Also known as: Whole breast irradiation

IORT with 50 kV x-rays, 20 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with breast cancer and a tumor diameter \< 3,5 cm plannend for breast conserving surgery. Intraoperative radiotherapy (IORT) is applied as an advanced boost with 20 Gy at the applicator surface during surgery. Its feasibility was already shown. IORT as a boost is considered as one of several boost techniques in the S3-Leitlinie (national guideline) for breast cancer.

You may qualify if:

• Tumor diameter \< 3,5 cm
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Medical Center Mannheim

Mannheim, 68167, Germany

Location

Related Publications (25)

• Andersen KG, Gartner R, Kroman N, Flyger H, Kehlet H. Persistent pain after targeted intraoperative radiotherapy (TARGIT) or external breast radiotherapy for breast cancer: a randomized trial. Breast. 2012 Feb;21(1):46-9. doi: 10.1016/j.breast.2011.07.011. Epub 2011 Aug 23.

  PMID: 21865044 BACKGROUND

• Sautter-Bihl ML, Sedlmayer F, Budach W, Dunst J, Engenhart-Cabillic R, Fietkau R, Feyer P, Haase W, Harms W, Rodel C, Souchon R, Wenz F, Sauer R. Intraoperative radiotherapy as accelerated partial breast irradiation for early breast cancer : beware of one-stop shops? Strahlenther Onkol. 2010 Dec;186(12):651-7. doi: 10.1007/s00066-010-8001-2.

  PMID: 21127826 BACKGROUND

• Vaidya JS, Baum M, Tobias JS, Wenz F, Massarut S, Keshtgar M, Hilaris B, Saunders C, Williams NR, Brew-Graves C, Corica T, Roncadin M, Kraus-Tiefenbacher U, Sutterlin M, Bulsara M, Joseph D. Long-term results of targeted intraoperative radiotherapy (Targit) boost during breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1091-7. doi: 10.1016/j.ijrobp.2010.07.1996. Epub 2010 Oct 15.

  PMID: 20951505 BACKGROUND

• Keshtgar MR, Vaidya JS, Tobias JS, Wenz F, Joseph D, Stacey C, Metaxas MG, Keller A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy for breast cancer in patients in whom external beam radiation is not possible. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):31-8. doi: 10.1016/j.ijrobp.2010.01.045. Epub 2010 Jun 18.

  PMID: 20646864 BACKGROUND

• Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sutterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010 Jul 10;376(9735):91-102. doi: 10.1016/S0140-6736(10)60837-9.

  PMID: 20570343 BACKGROUND

• Herskind C, Griebel J, Kraus-Tiefenbacher U, Wenz F. Sphere of equivalence--a novel target volume concept for intraoperative radiotherapy using low-energy X rays. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1575-81. doi: 10.1016/j.ijrobp.2008.08.009.

  PMID: 19028280 BACKGROUND

• Belletti B, Vaidya JS, D'Andrea S, Entschladen F, Roncadin M, Lovat F, Berton S, Perin T, Candiani E, Reccanello S, Veronesi A, Canzonieri V, Trovo MG, Zaenker KS, Colombatti A, Baldassarre G, Massarut S. Targeted intraoperative radiotherapy impairs the stimulation of breast cancer cell proliferation and invasion caused by surgical wounding. Clin Cancer Res. 2008 Mar 1;14(5):1325-32. doi: 10.1158/1078-0432.CCR-07-4453.

  PMID: 18316551 BACKGROUND

• Welzel G, Hofmann F, Blank E, Kraus-Tiefenbacher U, Hermann B, Sutterlin M, Wenz F. Health-related quality of life after breast-conserving surgery and intraoperative radiotherapy for breast cancer using low-kilovoltage X-rays. Ann Surg Oncol. 2010 Oct;17 Suppl 3:359-67. doi: 10.1245/s10434-010-1257-z. Epub 2010 Sep 19.

  PMID: 20853059 BACKGROUND

• Kraus-Tiefenbacher U, Blank E, Wenz F. Intraoperative radiotherapy during a second breast-conserving procedure for relapsed breast cancer after previous external beam radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1279-80. doi: 10.1016/j.ijrobp.2011.02.038. No abstract available.

  PMID: 21683889 BACKGROUND

• Wasser K, Ruch M, Brade J, Schoeber C, Kraus-Tiefenbacher U, Schnitzer A, Engel D, Wenz F, Sutterlin M, Schoenberg SO, Buesing KA. Do structural changes in the tumour bed after intraoperative radiotherapy (IORT) of breast cancer complicate the evaluation of mammograms in a long-term follow-up? Eur J Radiol. 2012 Mar;81(3):e255-9. doi: 10.1016/j.ejrad.2011.02.016. Epub 2011 Mar 4.

  PMID: 21376493 BACKGROUND

• Blank E, Kraus-Tiefenbacher U, Welzel G, Keller A, Bohrer M, Sutterlin M, Wenz F. Single-center long-term follow-up after intraoperative radiotherapy as a boost during breast-conserving surgery using low-kilovoltage x-rays. Ann Surg Oncol. 2010 Oct;17 Suppl 3:352-8. doi: 10.1245/s10434-010-1265-z. Epub 2010 Sep 19.

  PMID: 20853058 BACKGROUND

• Herskind C, Wenz F. Radiobiological comparison of hypofractionated accelerated partial-breast irradiation (APBI) and single-dose intraoperative radiotherapy (IORT) with 50-kV X-rays. Strahlenther Onkol. 2010 Aug;186(8):444-51. doi: 10.1007/s00066-010-2147-9. Epub 2010 Jul 29.

  PMID: 20803285 BACKGROUND

• Wenz F, Welzel G, Blank E, Hermann B, Steil V, Sutterlin M, Kraus-Tiefenbacher U. Intraoperative radiotherapy as a boost during breast-conserving surgery using low-kilovoltage X-rays: the first 5 years of experience with a novel approach. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1309-14. doi: 10.1016/j.ijrobp.2009.06.085. Epub 2010 Jan 25.

  PMID: 20100643 BACKGROUND

• Ruch M, Brade J, Schoeber C, Kraus-Tiefenbacher U, Schnitzer A, Engel D, Wenz F, Sutterlin M, Schoenberg SO, Wasser K. Long-term follow-up-findings in mammography and ultrasound after intraoperative radiotherapy (IORT) for breast cancer. Breast. 2009 Oct;18(5):327-34. doi: 10.1016/j.breast.2009.09.010.

  PMID: 19909898 BACKGROUND

• Kraus-Tiefenbacher U, Welzel G, Brade J, Hermann B, Siebenlist K, Wasser KS, Schneider FS, Sutterlin M, Wenz F. Postoperative seroma formation after intraoperative radiotherapy using low-kilovoltage X-rays given during breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1140-5. doi: 10.1016/j.ijrobp.2009.06.008. Epub 2009 Oct 14.

  PMID: 19836152 BACKGROUND

• Wenz F, Budach W, Dunst J, Feyer P, Haase W, Harms W, Sautter-Bihl ML, Sedlmayer F, Souchon R, Sauer R; DEGRO Expert Panel Breast Cancer. Accelerated partial-breast irradiation (APBI)--ready for prime time? Strahlenther Onkol. 2009 Oct;185(10):653-5. doi: 10.1007/s00066-009-8002-1. No abstract available.

  PMID: 19806329 BACKGROUND

• Wenz F, Welzel G, Keller A, Blank E, Vorodi F, Herskind C, Tome O, Sutterlin M, Kraus-Tiefenbacher U. Early initiation of external beam radiotherapy (EBRT) may increase the risk of long-term toxicity in patients undergoing intraoperative radiotherapy (IORT) as a boost for breast cancer. Breast. 2008 Dec;17(6):617-22. doi: 10.1016/j.breast.2008.05.009. Epub 2008 Jul 22.

  PMID: 18650091 BACKGROUND

• Kraus-Tiefenbacher U, Bauer L, Scheda A, Schoeber C, Schaefer J, Steil V, Wenz F. Intraoperative radiotherapy (IORT) is an option for patients with localized breast recurrences after previous external-beam radiotherapy. BMC Cancer. 2007 Sep 14;7:178. doi: 10.1186/1471-2407-7-178.

  PMID: 17854511 BACKGROUND

• Wasser K, Schoeber C, Kraus-Tiefenbacher U, Bauer L, Brade J, Teubner J, Wenz F, Neff W. Early mammographic and sonographic findings after intraoperative radiotherapy (IORT) as a boost in patients with breast cancer. Eur Radiol. 2007 Jul;17(7):1865-74. doi: 10.1007/s00330-006-0556-z. Epub 2007 Jan 20.

  PMID: 17237946 BACKGROUND

• Vaidya JS, Baum M, Tobias JS, Massarut S, Wenz F, Murphy O, Hilaris B, Houghton J, Saunders C, Corica T, Roncadin M, Kraus-Tiefenbacher U, Melchaert F, Keshtgar M, Sainsbury R, Douek M, Harrison E, Thompson A, Joseph D. Targeted intraoperative radiotherapy (TARGIT) yields very low recurrence rates when given as a boost. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1335-8. doi: 10.1016/j.ijrobp.2006.07.1378. Epub 2006 Nov 2.

  PMID: 17084562 BACKGROUND

• Kraus-Tiefenbacher U, Bauer L, Scheda A, Fleckenstein K, Keller A, Herskind C, Steil V, Melchert F, Wenz F. Long-term toxicity of an intraoperative radiotherapy boost using low energy X-rays during breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2006 Oct 1;66(2):377-81. doi: 10.1016/j.ijrobp.2006.05.042. Epub 2006 Aug 2.

  PMID: 16887294 BACKGROUND

• Kraus-Tiefenbacher U, Bauer L, Kehrer T, Hermann B, Melchert F, Wenz F. Intraoperative radiotherapy (IORT) as a boost in patients with early-stage breast cancer -- acute toxicity. Onkologie. 2006 Mar;29(3):77-82. doi: 10.1159/000091160. Epub 2006 Mar 3.

  PMID: 16514267 BACKGROUND

• Kraus-Tiefenbacher U, Scheda A, Steil V, Hermann B, Kehrer T, Bauer L, Melchert F, Wenz F. Intraoperative radiotherapy (IORT) for breast cancer using the Intrabeam system. Tumori. 2005 Jul-Aug;91(4):339-45. doi: 10.1177/030089160509100411.

  PMID: 16277101 BACKGROUND

• Pez M, Keller A, Welzel G, Abo-Madyan Y, Ehmann M, Tuschy B, Berlit S, Sutterlin M, Wenz F, Giordano FA, Sperk E. Long-term outcome after intraoperative radiotherapy as a boost in breast cancer. Strahlenther Onkol. 2020 Apr;196(4):349-355. doi: 10.1007/s00066-019-01525-7. Epub 2019 Oct 22.

  PMID: 31641788 BACKGROUND

• Goerdt L, Poemsl J, Spaich S, Welzel G, Abo-Madyan Y, Ehmann M, Berlit S, Tuschy B, Sutterlin M, Wenz F, Sperk E. Longitudinal cosmetic outcome after planned IORT boost with low kV X-rays-monocentric results from the TARGIT BQR registry. Transl Cancer Res. 2023 Jul 31;12(7):1715-1726. doi: 10.21037/tcr-23-88. Epub 2023 Jun 27.

  PMID: 37588731 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

902 patients were available for any analysis. Be aware that 8 patients with both sided cancers were included. So there were 910 affected breasts in 902 patients.

Results Point of Contact

• Title: PD Dr. med. Elena Sperk
• Organization: Medical Faculty Mannheim, Heidelberg University

elena.sperk@medma.uni-heidelberg.de

+496213838624

Study Officials

• Elena Sperk, MD

  Universitätsmedizin Mannheim

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Managing Director Clinical Trials Unit Mannheim Cancer Center

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-12

Locations

DE (1)