Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00014612
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2001-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4813}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2001-04-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axillary recurrence rate', 'timeFrame': 'from randomization'}], 'secondaryOutcomes': [{'measure': 'Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery', 'timeFrame': 'from randomization'}, {'measure': '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', 'timeFrame': 'from randomization'}, {'measure': 'Axillary recurrence-free survival', 'timeFrame': 'from randomization'}, {'measure': 'Disease-free survival', 'timeFrame': 'from randomization'}, {'measure': 'Overall survival', 'timeFrame': 'from randomization'}]}, 'conditionsModule': {'keywords': ['stage IA breast cancer', 'stage IB breast cancer', 'stage II breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20038733', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20300966', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '13129630', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26488192', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25439688', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '23522754', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.\n* Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.\n* Compare the morbidity of patients treated with these regimens.\n* Compare the quality of life of these patients treated with these regimens.\n\nOUTLINE: 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.\n\nPatients 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.\n\n* Arm I: Within 8 weeks after surgery, patients undergo complete ALND.\n* Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.\n\nPatients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.\n\nQuality of life is assessed at baseline and then at 1, 2, 3, and 5 years.\n\nPatients are followed annually for 5 years.\n\nPROJECTED 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer\n\n * T0-2, N0\n * Diagnosis by excisional tumorectomy allowed\n * Clinically occult invasive disease must be histologically confirmed\n* Only 1 tumor in 1 breast\n\n * Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI\n\n * Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed\n * Multicentric (i.e., in different quadrants) breast cancer is not allowed\n* Clinically negative axillary lymph nodes\n* No metastatic disease\n* No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance\n* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to axilla\n\nSurgery:\n\n* No prior surgery to axilla\n\nOther:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00014612', 'acronym': 'AMAROS', 'briefTitle': 'Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'After Mapping Of The Axilla: Radiotherapy Or Surgery', 'orgStudyIdInfo': {'id': 'EORTC-10981-22023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'axillary lymph node dissection', 'description': 'complete axillary lymph node dissection', 'interventionNames': ['Procedure: axillary lymph node dissection', 'Procedure: lymphoscintigraphy', 'Procedure: therapeutic conventional surgery']}, {'type': 'EXPERIMENTAL', 'label': 'axillary radiotherapy', 'description': 'axillary radiotherapy, daily for 5 days a week, for 5 weeks', 'interventionNames': ['Procedure: lymphoscintigraphy', 'Procedure: therapeutic conventional surgery', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'axillary lymph node dissection', 'type': 'PROCEDURE', 'armGroupLabels': ['axillary lymph node dissection']}, {'name': 'lymphoscintigraphy', 'type': 'PROCEDURE', 'armGroupLabels': ['axillary lymph node dissection', 'axillary radiotherapy']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['axillary lymph node dissection', 'axillary radiotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['axillary radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hopital de la Tronche', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '1 (50134)', 'city': 'Firenze (Florence)', 'country': 'Italy', 'facility': 'Universita Degli Studi di Florence - Policlinico di Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '10123', 'city': 'Turin', 'country': 'Italy', 'facility': 'Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '1180AH', 'city': 'Amstelveen', 'country': 'Netherlands', 'facility': 'Ziekenhuis Amstelland', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum at University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen - Lokatie Lukas', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '6800 TA', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': 'NL 2600 GA', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Group - Delft', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': 'NL-9200 DA', 'city': 'Drachten', 'country': 'Netherlands', 'facility': 'NIJ Smellinghe', 'geoPoint': {'lat': 53.11254, 'lon': 6.0989}}, {'zip': '5602 ZA', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '9713 EZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2000', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis - Locatie EG', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '7770', 'city': 'Hardenberg', 'country': 'Netherlands', 'facility': 'Ropcke-Zweers Ziekenhuis', 'geoPoint': {'lat': 52.57583, 'lon': 6.61944}}, {'zip': '3840 AC', 'city': 'Harderwijk', 'country': 'Netherlands', 'facility': 'Ziekenhuis St. Jansdal', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6043 CV', 'city': 'Roermond', 'country': 'Netherlands', 'facility': 'Saint Laurentius Ziekenhuis', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis - Locatie Leyenburg', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '2566 MJ', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis - Locatie Rode Kruis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '2597AX', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Ziekenhuis Bronovo', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': 'Sl-1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology - Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopital Cantonal Universitaire de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '81190', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'M23 9LJ', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CF14 4XN', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Emiel JT Rutgers', 'role': 'STUDY_CHAIR', 'affiliation': 'The Netherlands Cancer Institute'}, {'name': 'Robert Mansel', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff'}, {'name': 'Cornelis Van De Velde', 'role': 'STUDY_CHAIR', 'affiliation': 'Leiden University Medical Centre, Leiden'}, {'name': 'Geertjan Van Tienhoven', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'collaborators': [{'name': 'ALMANAC Trialists Group', 'class': 'UNKNOWN'}, {'name': 'Borstkanker Onderzoeksgroup Nederland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}