Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-Risk Invasive Carcinoma and Low-Risk Ductal Carcinoma in Situ (DCIS) of the Female Breast - Full Text View

Sponsored by:	University of Erlangen-Nürnberg
Information provided by:	University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:	NCT00402519

Purpose

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Condition	Intervention	Phase
Breast Cancer	Procedure: Accelerated partial breast irradiation Procedure: External beam whole breast irradiation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-Risk Invasive Carcinoma and Low-Risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy Surgery

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:

Local control

Secondary Outcome Measures:

Incidence and severity of acute and late side effects
Differences in cosmetic results
Distant metastases free survival
Survival rates (Overall Survival, Disease-free Survival)
Contralateral breast cancer rate
Quality-of-Life

Estimated Enrollment:	1170
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage 0, I or II breast cancer.
Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
Ductal carcinoma in situ (DCIS) alone.
No lymph invasion (L0) and no hemangiosis (V0).
Lesions of > 3 cm diameter, histopathologically confirmed.
pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional.
M0.
Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
For DCIS only: lesions must be classified as low or intermediate risk group (Van Nuys Prognostic Index <8).
Unifocal and unicentric DCIS or breast cancer.
Age >= 40 years.
Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
Signed study-specific consent form prior to randomization.

Exclusion Criteria:

Stage III or IV breast cancer.
Surgical margins that cannot be microscopically assessed.
Extensive intraductal component (EIC).
Paget’s disease or pathological skin involvement.
Synchronous or previous breast cancer.
Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma FIGO 0 and I if patient is continuously disease-free.
Pregnant or lactating women.
Collagen vascular disease.
The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar.
Psychiatric disorders.
Patient with breast deemed technically unsatisfactory for brachytherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402519

Contacts

Contact: Oliver J Ott, MD

+49 9131 8532935

oliver.ott@strahlen.imed.uni-erlangen.de

Locations

Austria
University Hospital AKH Wien, Department of Radiotherapy and Radiobiology	Recruiting
Vienna, Austria
Contact: Richard Pötter, MD Richard.Poetter@akhwien.at
Principal Investigator: Richard Pötter, MD
Sub-Investigator: Daniela Kauer-Dorner, MD
Germany
University Hospital Erlangen, Department of Radiation Oncology	Recruiting
Erlangen, Germany, 91054
Contact: Oliver J Ott, MD +49 9131 8532935 oliver.ott@strahlen.imed.uni-erlangen.de
Principal Investigator: Vratislav Strnad, MD
Principal Investigator: Oliver J Ott, MD
University Hospital Kiel, Department of Radiation Oncology	Recruiting
Kiel, Germany
Contact: Peter Niehoff, MD niehoff@onco.uni-kiel.de
Principal Investigator: Peter Niehoff, MD
University Hospital Leipzig, Department of Radiation Oncology	Recruiting
Leipzig, Germany
Contact: Guido Hildebrandt, MD hilg@medizin.uni-leipzig.de
Principal Investigator: Guido Hildebrandt, MD
University Hospital Lübeck, Department of Radiation Oncology	Recruiting
Lübeck, Germany
Contact: Gyoergy Kovacs, MD gyoergy.kovacs@uk-sh.de
Principal Investigator: Gyoergy Kovacs, MD
Hospital Barmherzige Brüder, Department of Radiation Oncology	Recruiting
Regensburg, Germany
Contact: Michael Allgäuer, MD michael.allgaeuer@barmherzige-regensburg.de
Principal Investigator: Michael Allgäuer, MD
Sub-Investigator: Michael Gessl, MD
University Hospital Rostock, Department of Radiation Oncology	Recruiting
Rostock, Germany
Contact: Rainer Fietkau, MD rainer.fietkau@med.uni-rostock.de
Principal Investigator: Rainer Fietkau, MD
Sub-Investigator: Hellen Knauerhase, MD
Hungary
National Institute of Oncology, Department of Radiation Oncology	Recruiting
Budapest, Hungary
Contact: Csaba Polgár, MD polgar@oncol.hu
Principal Investigator: Csaba Polgar, MD
Sub-Investigator: Tibor Major, PhD
Poland
Kierownik Zakladu Brachyterapii, Cetrum Onkologii	Recruiting
Warszawa, Poland
Contact: Jaroslaw Lyczek, MD jaroslawlyczek@wp.pl
Principal Investigator: Jaroslaw Lyczek, MD
Spain
Catalan Institut of Oncology, Department of Radiation Oncology	Recruiting
Barcelona, Spain, 08907
Contact: Ferran Guedea, MD guedea@ico.scs.es
Principal Investigator: Ferran Guedea, MD
Sub-Investigator: Alfredo Polo, MD
Valencian Institut of Oncology, Department of Radiation Oncology	Recruiting
Valencia, Spain, 46009
Contact: Jose Luis Guinot, MD jlguinot@comv.es
Principal Investigator: Jose Luis Guinot, MD
Sub-Investigator: L. Arribas, MD

Sponsors and Collaborators

University of Erlangen-Nürnberg

Investigators

Study Chair:	Vratislav Strnad, MD	University Hospital Erlangen, Germany
Study Chair:	Csaba Polgár, MD	National Institute of Oncology Budapest, Hungary
Study Director:	Oliver J Ott, MD	University Hospital Erlangen, Germany

More Information

Additional Information:

Trial Homepage with a short version of the protocol This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GEC-ESTRO APBI Trial
Study First Received:	November 21, 2006
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00402519 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg:

accelerated partial breast irradiation
multicatheter brachytherapy
high dose rate brachytherapy
pulsed dose rate brachytherapy

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Site

Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009