TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry
NCT ID: NCT01440010
Last Updated: 2025-12-12
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
1133 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-09-01
Study Completion Date
2020-12-31
Brief Summary
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Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT
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Detailed Description
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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.
Conditions
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Breast Cancer
Study Design
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Observational Model Type
ECOLOGIC_OR_COMMUNITY
Study Time Perspective
PROSPECTIVE
Study Groups
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IORT with 50 kV x-rays, 20 Gy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
IORT with 20 Gy
Intervention Type
RADIATION
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Interventions
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IORT with 20 Gy
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Intervention Type
RADIATION
Other Intervention Names
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Whole breast irradiation
Eligibility Criteria
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Inclusion Criteria
* Tumor diameter \< 3,5 cm
* Informed consent
* Informed consent
Exclusion Criteria
* No informed consent
* Tumor size \> 3,5 cm
* No indication for a boost
* Tumor size \> 3,5 cm
* No indication for a boost
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Universitätsmedizin Mannheim
OTHER
Sponsor Role
lead
Responsible Party
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Elena Sperk, MD
Senior Consultant, Managing Director Clinical Trials Unit Mannheim Cancer Center
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elena Sperk, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsmedizin Mannheim
Locations
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University Medical Center Mannheim
Mannheim, , Germany
Site Status
Countries
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Germany
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TARGIT BQR
Identifier Type: -
Identifier Source: org_study_id
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