Studieoverzicht - 2001-02 AMAROS

Number 2001-02 AMAROS
Nickname AMAROS
Status Closed Date: 30-04-2010
Inclusion closed
Other study number(s) EORTC 10981/22023 CKTO 2000
Participating parties/groups EORTC, ALMANAC
Full title After Mapping of the Axilla: Radiotherapy Or Surgery
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 4067
Actual accrual 4620 Date: 07-12-2009
Estimated study completion date 31-12-2010
CCMO approval Not applicable Date: Nr:
EudraCT nr. NA
Trial Register NCT00014612
METC approval Yes Date: 20-07-2000 METC: Nederlands Kanker Instituut Nr:
Amendments Yes Date: 22-02-2008
KWF-CKS approval Yes Date: 20-07-2000 Nr: 22023 CKTO 2000
News item
Sponsor EORTC
Principal Investigator(s) E.J.Th. Rutgers, G.J. van Tienhoven
Study manager Aleksandra Perić, PhD
EORTC, Project Manager
Tel: +32 2 774 1043 * Fax: +32 2 772 6701
Central datamanagement and randomization EORTC (European Organisation for Research and Treatment of Cancer)
Avenue E. Mounier 83-11
B-1200, Brussels, Belgium
Tel +32 2 774 16 11
Monitoring Quality control via dummy runs
Local datamanagement IKNL
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF


Arm A: complete axillary lymph node dissection
Arm B: radiotherapy to the axilla


To prove equivalent local/regional control for patients with proven axillary lymph node metastasis by sentinel node biopsy with reduced morbidity if treated with axillary radiotherapy instead of axillary lymph node dissection. A second objective is to investigate whether adequate axillary control can be obtained by not subjecting patients with a negative sentinel lymph node to axillary lymph node dissection.


Primary endpoint:

  • Axillary recurrence free rate in the axillary lymph node dissection treatment group at 5 years

Secondary endpoints:

  • Overall survival
  • Axillary recurrence free survival
  • Shoulder function
  • Quality of life
Main eligibility criteria:
  • T1,2 (> 5 mm and < 50 mm), N0 M0
  • Age >=18
  • Pre-and postmenopausal
  • Female patients
Documents (public):
Documents (protected):
In order to see this content you need to be logged on.