Clinical trial NCT00392184: Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
Official title: Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: accelerated partial breast irradiation
multicatheter brachytherapy
high dose rate brachytherapy
pulsed dose rate brachytherapy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 274
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.


Eligibility criteria: Inclusion Criteria:

* pT1/2 (≤ 3 cm)
* pN0 or pN1 mi
* M0 and no contralateral BC
* Clear margins (≥ 2 mm)
* Age ≥ 35 years
* ER and/or PR positive

Exclusion Criteria:

* Multifocality or Multicentricity
* EIC
* Lymphovascular invasion
* Poorly differentiated tumors
* Diffuse microcalcifications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Hospital Barmherzige Schwestern Linz
city: Vienna
country: Austria
facility: University Hospital AKH Vienna
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Leipzig
country: Germany
facility: University Hospital Leipzig
Study officials:
affiliation: University Hospital Erlangen, Germany
name: Vratislav Strnad, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Germany
name: Oliver J Ott, MD
role: STUDY_DIRECTOR
affiliation: University Hospital Leipzig, Germany
name: Guido Hildebrandt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital AKH Vienna, Austria
name: Richard Pötter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Barmherzige Schwestern Linz, Austria
name: Joe Hammer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ott OJ, Potter R, Hammer J, Hildebrandt G, Lotter M, Resch A, Pohls U, Beckmann MW, Sauer R, Strnad V. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial. Strahlenther Onkol. 2004 Oct;180(10):642-9. doi: 10.1007/s00066-004-1294-2.
citation: Strnad V, Ott O, Potter R, Hildebrandt G, Hammer J, Resch A, Lotter M, Ackermann S, Beckmann MW, Sauer R. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy. 2004;3(3):115-9. doi: 10.1016/j.brachy.2004.08.003.
citation: Ott OJ, Potter R, Hildebrandt G, Hammer J, Lotter M, Beckmann MW, Sauer R, Strnad V. [Partial breast irradiation for early breast cancer with favorable prognostic factors: 3-year results of the German-Austrian phase II-trial]. Rofo. 2005 Jul;177(7):962-7. doi: 10.1055/s-2005-858268. German.
citation: Ott OJ, Hildebrandt G, Potter R, Hammer J, Hindemith M, Resch A, Spiegl K, Lotter M, Uter W, Kortmann RD, Schrauder M, Beckmann MW, Fietkau R, Strnad V. Accelerated partial breast irradiation with interstitial implants: risk factors associated with increased local recurrence. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1458-63. doi: 10.1016/j.ijrobp.2010.04.032. Epub 2010 Aug 2.