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

Breast Cancer Clinical Trial

— TARGIT_BQR  

Official title:

TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440010
• Other study ID #: TARGIT BQR
• Status: Completed
• Start date: September 1, 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2022
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1135
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Tumor diameter < 3,5 cm
• Informed consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• IORT with 50 kV x-rays, 20 Gy
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Locations

Country	Name	City	State
Germany	University Medical Center Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (24)

Andersen KG, Gärtner 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. — View Citation

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, Trovò 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. — View Citation

Blank E, Kraus-Tiefenbacher U, Welzel G, Keller A, Bohrer M, Sütterlin 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Mar 3. — View Citation

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. Epub 2006 Aug 2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kraus-Tiefenbacher U, Welzel G, Brade J, Hermann B, Siebenlist K, Wasser KS, Schneider FS, Sütterlin 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. — View Citation

Pez M, Keller A, Welzel G, Abo-Madyan Y, Ehmann M, Tuschy B, Berlit S, Sütterlin 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. — View Citation

Ruch M, Brade J, Schoeber C, Kraus-Tiefenbacher U, Schnitzer A, Engel D, Wenz F, Sütterlin 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. — View Citation

Sautter-Bihl ML, Sedlmayer F, Budach W, Dunst J, Engenhart-Cabillic R, Fietkau R, Feyer P, Haase W, Harms W, Rödel 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. — View Citation

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. Epub 2006 Nov 2. — View Citation

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, Sütterlin 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. — View Citation

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, Sütterlin 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. Erratum in: Lancet. 2010 Jul 10;376(9735):90. — View Citation

Wasser K, Ruch M, Brade J, Schoeber C, Kraus-Tiefenbacher U, Schnitzer A, Engel D, Wenz F, Sütterlin 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. — View Citation

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. Epub 2007 Jan 20. — View Citation

Welzel G, Hofmann F, Blank E, Kraus-Tiefenbacher U, Hermann B, Sütterlin 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. — View Citation

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. — View Citation

Wenz F, Welzel G, Blank E, Hermann B, Steil V, Sütterlin 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. — View Citation

Wenz F, Welzel G, Keller A, Blank E, Vorodi F, Herskind C, Tomé O, Sütterlin 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence rate		5 years
Secondary	Toxicity, Overall survival	LENT SOMA Scale for toxicity regular follow up	5 years