Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer (AMAROS)
|ClinicalTrials.gov Identifier: NCT00014612|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 29, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4813 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||After Mapping Of The Axilla: Radiotherapy Or Surgery|
|Study Start Date :||February 2001|
|Primary Completion Date :||November 2010|
|Study Completion Date :||March 2013|
Active Comparator: axillary lymph node dissection
complete axillary lymph node dissection
|Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery|
Experimental: axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
|Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy|
- Axillary recurrence rate [ Time Frame: from randomization ]
- Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery [ Time Frame: from randomization ]
- Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery [ Time Frame: from randomization ]
- Axillary recurrence-free survival [ Time Frame: from randomization ]
- Disease-free survival [ Time Frame: from randomization ]
- Overall survival [ Time Frame: from randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014612
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, 38043|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Universita Degli Studi di Florence - Policlinico di Careggi|
|Firenze (Florence), Italy, 1 (50134)|
|Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino|
|Turin, Italy, 10123|
|HagaZiekenhuis - Locatie Leyenburg|
|'s-Gravenhage, Netherlands, 2545 CH|
|Amstelveen, Netherlands, 1180AH|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Gelre Ziekenhuizen - Lokatie Lukas|
|Apeldoorn, Netherlands, 7334 DZ|
|Arnhem, Netherlands, 6800 TA|
|Reinier de Graaf Group - Delft|
|Delft, Netherlands, NL 2600 GA|
|HagaZiekenhuis - Locatie Rode Kruis|
|Den Haag, Netherlands, 2566 MJ|
|Den Haag, Netherlands, 2597AX|
|Drachten, Netherlands, NL-9200 DA|
|Eindhoven, Netherlands, 5602 ZA|
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 EZ|
|Kennemer Gasthuis - Locatie EG|
|Haarlem, Netherlands, 2000|
|Hardenberg, Netherlands, 7770|
|Ziekenhuis St. Jansdal|
|Harderwijk, Netherlands, 3840 AC|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Saint Laurentius Ziekenhuis|
|Roermond, Netherlands, 6043 CV|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Institute of Oncology - Ljubljana|
|Ljubljana, Slovenia, Sl-1000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Marmara University Hospital|
|Istanbul, Turkey, 81190|
|Manchester, England, United Kingdom, M23 9LJ|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XN|
|Study Chair:||Emiel JT Rutgers||The Netherlands Cancer Institute|
|Study Chair:||Robert Mansel||Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff|
|Study Chair:||Cornelis Van De Velde||Leiden University Medical Centre, Leiden|
|Study Chair:||Geertjan Van Tienhoven||Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam|