Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
NCT ID: NCT00014612
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4813 participants
INTERVENTIONAL
2001-02-28
2013-03-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
Detailed Description
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* Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
* Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
* Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
* Compare the morbidity of patients treated with these regimens.
* Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
* Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
* Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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axillary lymph node dissection
complete axillary lymph node dissection
axillary lymph node dissection
lymphoscintigraphy
therapeutic conventional surgery
axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
lymphoscintigraphy
therapeutic conventional surgery
radiation therapy
Interventions
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axillary lymph node dissection
lymphoscintigraphy
therapeutic conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer
* T0-2, N0
* Diagnosis by excisional tumorectomy allowed
* Clinically occult invasive disease must be histologically confirmed
* Only 1 tumor in 1 breast
* Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI
* Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
* Multicentric (i.e., in different quadrants) breast cancer is not allowed
* Clinically negative axillary lymph nodes
* No metastatic disease
* No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Any age
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to axilla
Surgery:
* No prior surgery to axilla
Other:
* See Disease Characteristics
FEMALE
No
Sponsors
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ALMANAC Trialists Group
UNKNOWN
Borstkanker Onderzoeksgroup Nederland
UNKNOWN
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Emiel JT Rutgers
Role: STUDY_CHAIR
The Netherlands Cancer Institute
Robert Mansel
Role: STUDY_CHAIR
Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff
Cornelis Van De Velde
Role: STUDY_CHAIR
Leiden University Medical Centre, Leiden
Geertjan Van Tienhoven
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam
Locations
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CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Universita Degli Studi di Florence - Policlinico di Careggi
Firenze (Florence), , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, , Italy
Ziekenhuis Amstelland
Amstelveen, , Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Reinier de Graaf Group - Delft
Delft, , Netherlands
NIJ Smellinghe
Drachten, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Kennemer Gasthuis - Locatie EG
Haarlem, , Netherlands
Ropcke-Zweers Ziekenhuis
Hardenberg, , Netherlands
Ziekenhuis St. Jansdal
Harderwijk, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
Saint Laurentius Ziekenhuis
Roermond, , Netherlands
HagaZiekenhuis - Locatie Leyenburg
The Hague, , Netherlands
HagaZiekenhuis - Locatie Rode Kruis
The Hague, , Netherlands
Ziekenhuis Bronovo
The Hague, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Institute of Oncology - Ljubljana
Ljubljana, , Slovenia
Hopital Cantonal Universitaire de Geneve
Geneva, , Switzerland
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Wythenshawe Hospital
Manchester, England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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References
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Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Demonty G, Duez N, Cataliotti L, Klinkenbijl J, Westenberg HA, van der Mijle H, Hurkmans C, Rutgers EJ. Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. J Clin Oncol. 2010 Feb 10;28(5):731-7. doi: 10.1200/JCO.2008.21.7554. Epub 2009 Dec 28.
Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H, Snoj M, Hurkmans C, Rutgers EJ. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010 Jul;17(7):1854-61. doi: 10.1245/s10434-010-0945-z. Epub 2010 Mar 19.
Straver ME, Meijnen P, van Tienhoven G, et al.: Technical aspects of the sentinel node biopsy in the EORTC AMAROS sentinel node trial. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1006, 2008.
Meijnen P, Rutgers EJT, van de Velde CJH, et al.: EORTC 10981-22023 trial. AMAROS: after mapping of the axilla: radiotherapy or surgery? Trial update. [Abstract] Eur J Cancer 2 (Suppl 3): A-79, 79, 2004.
Hurkmans CW, Borger JH, Rutgers EJ, van Tienhoven G; EORTC Breast Cancer Cooperative Group; Radiotherapy Cooperative Group. Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol. 2003 Sep;68(3):233-40. doi: 10.1016/s0167-8140(03)00194-4.
Donker M, Slaets L, van Tienhoven G, Rutgers EJ. [Axillary lymph node dissection versus axillary radiotherapy in patients with a positive sentinel node: the AMAROS trial]. Ned Tijdschr Geneeskd. 2015;159:A9302. Dutch.
Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.
Donker M, Straver ME, van Tienhoven G, van de Velde CJ, Mansel RE, Litiere S, Werutsky G, Duez NJ, Orzalesi L, Bouma WH, van der Mijle H, Nieuwenhuijzen GA, Veltkamp SC, Helen Westenberg A, Rutgers EJ. Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: identification rate and nodal outcome. Eur J Cancer. 2013 Jun;49(9):2093-100. doi: 10.1016/j.ejca.2013.02.017. Epub 2013 Mar 19.
Other Identifiers
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EORTC-10981-22023
Identifier Type: -
Identifier Source: org_study_id