APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00402519
First received: November 21, 2006
Last updated: February 18, 2010
Last verified: February 2010
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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 |
Radiation: Accelerated partial breast irradiation Radiation: External beam whole breast irradiation |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- Local control [ Time Frame: 5-years, 10 ten-years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence and severity of acute and late side effects [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- Differences in cosmetic results [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- Distant metastases free survival [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- Survival rates (Overall Survival, Disease-free Survival) [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- Contralateral breast cancer rate [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- Quality-of-Life [ Time Frame: 5-years ] [ Designated as safety issue: No ]
Enrollment: | 1300 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2014 |
Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: APBI |
Radiation: Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
|
Active Comparator: EBRT |
Radiation: External beam whole breast irradiation
Standard Whole breast irradiation
|
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
Locations
Austria | |
University Hospital AKH Wien, Department of Radiotherapy and Radiobiology | |
Vienna, Austria | |
Germany | |
University Hospital Erlangen, Department of Radiation Oncology | |
Erlangen, Germany, 91054 | |
University Hospital Kiel, Department of Radiation Oncology | |
Kiel, Germany | |
University Hospital Leipzig, Department of Radiation Oncology | |
Leipzig, Germany | |
University Hospital Lübeck, Department of Radiation Oncology | |
Lübeck, Germany | |
Hospital Barmherzige Brüder, Department of Radiation Oncology | |
Regensburg, Germany | |
University Hospital Rostock, Department of Radiation Oncology | |
Rostock, Germany | |
Hungary | |
National Institute of Oncology, Department of Radiation Oncology | |
Budapest, Hungary | |
Poland | |
Kierownik Zakladu Brachyterapii, Cetrum Onkologii | |
Warszawa, Poland | |
Spain | |
Catalan Institut of Oncology, Department of Radiation Oncology | |
Barcelona, Spain, 08907 | |
Valencian Institut of Oncology, Department of Radiation Oncology | |
Valencia, Spain, 46009 |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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:
No publications provided
Keywords provided by University of Erlangen-Nürnberg Medical School:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2013
Additional Information:
No publications provided
Responsible Party: | Dr. med. Bernd Gebhardt MBA, University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00402519 History of Changes |
Other Study ID Numbers: | GEC-ESTRO APBI Trial |
Study First Received: | November 21, 2006 |
Last Updated: | February 18, 2010 |
Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Erlangen-Nürnberg Medical School:
accelerated partial breast irradiation multicatheter brachytherapy high dose rate brachytherapy pulsed dose rate brachytherapy |
Additional relevant MeSH terms:
Breast Neoplasms Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on March 06, 2013