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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Complete Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Sentinel Lymph Node-Positive Women With Operable Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Any age	Other	EORTC-10981 EORTC-10981-AMAROS, NCT00014612

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Any age
• Measurable or evaluable disease
• No metastatic cancer
• No previous radiation therapy or surgery to the underarm area
• No previous therapy for invasive breast cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

All patients will undergo lymphoscintigraphy. They will then undergo surgery to remove either the tumor or the entire breast. Within 8 weeks after surgery, patients will be randomly assigned to one of two groups. Patients in group one will undergo complete axillary lymph node dissection. Patients in group two will undergo radiation therapy to the axillary lymph nodes 5 days a week for 5 weeks. Some patients in group one may also receive radiation therapy to the axillary lymph nodes. Quality of life will be assessed periodically. Patients will be evaluated once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Emiel Rutgers, MD, PhD, FRCS, Study coordinator		Ph: 31-20-512-2551

France
	Grenoble
	CHU de Grenoble - Hopital de la Tronche
		Contact Person	Ph:  33-4-7676-5537
	Lille
	Centre Oscar Lambret
		Contact Person	Ph:  33-20-29-5959
Italy
	Firenze (Florence)
	Universita Degli Studi di Florence - Policlinico di Careggi
		Contact Person	Ph:  39-43-780-51
	Turin
	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
		Contact Person	Ph:  39-575-4821
Netherlands
	Amstelveen
	Ziekenhuis Amstelland
		Contact Person	Ph:  31-020-347-4481
	Amsterdam
	Academisch Medisch Centrum at University of Amsterdam
		Contact Person	Ph:  31-20-566-9111
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		Contact Person	Ph:  31-20-512-9111
	Apeldoorn
	Gelre Ziekenhuizen - Lokatie Lukas
		Contact Person	Ph:  31-55-581-8181
	Arnhem
	Rijnstate Hospital
		Contact Person	Ph:  31-26-378-8888
	Delft
	Reinier de Graaf Group - Delft
		Contact Person	Ph:  31-15-260-3060
	Den Haag
	HagaZiekenhuis - Locatie Rode Kruis
		Contact Person	Ph:  31-70-360-8068
	Ziekenhuis Bronovo
		Contact Person	Ph:  31-070-312-4141
	Drachten
	NIJ Smellinghe
		Contact Person	Ph:  31-512-588-888
	Eindhoven
	Catharina Ziekenhuis
		Contact Person	Ph:  31-40-239-9111
	Groningen
	University Medical Center Groningen
		Contact Person	Ph:  31-50-361-6161
	Haarlem
	Kennemer Gasthuis - Locatie EG
		Contact Person
			Email: info@kg.nl
	Hardenberg
	Ropcke-Zweers Ziekenhuis
		Contact Person	Ph:  31-523-27-6000
	Harderwijk
	Ziekenhuis St. Jansdal
		Contact Person	Ph:  31-341-463-911
	Leiden
	Leiden University Medical Center
		Contact Person	Ph:  31-71-526-911
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		Contact Person	Ph:  31-24-361-5215
	Roermond
	Saint Laurentius Ziekenhuis
		Contact Person	Ph:  31-475-382-466
	's-Gravenhage
	HagaZiekenhuis - Locatie Leyenburg
		Contact Person	Ph:  31-70-359-2653
	Utrecht
	University Medical Center Utrecht
		Contact Person	Ph:  31-30-250-6266
Poland
	Gdansk
	Medical University of Gdansk
		Contact Person	Ph:  48-58-349-2000
Slovenia
	Ljubljana
	Institute of Oncology - Ljubljana
		Contact Person	Ph:  386-1-323-063
Switzerland
	Geneva
	Hopital Cantonal Universitaire de Geneve
		Contact Person	Ph:  41-22-372-4018
Turkey
	Istanbul
	Marmara University Hospital
		Contact Person	Ph:  90-216-327-4142
United Kingdom
England
	Manchester
	Wythenshawe Hospital
		Contact Person	Ph:  44-161-998-7070
Wales
	Cardiff
	University Hospital of Wales
		Contact Person	Ph:  44-29-2074-2896

Registry Information
Official Title		After Mapping Of The Axilla: Radiotherapy Or Surgery
Trial Start Date		2001-02-15
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00014612
Date Submitted to PDQ		2001-02-23
Information Last Verified		2009-07-21

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