AMAROS

BOOG 2001-02

General Information

BOOG number

BOOG 2001-02

Nickname

AMAROS

Status

Date: 30/04/2010

Participating parties / group

EORTC, ALMANAC

Other study number

EORTC 10981/22023 CKTO 2000

Full title

After Mapping of the Axilla: Radiotherapy Or Surgery

Indication

Subindication

Not applicable

Target sample size

4067

Actual accrual

4620
Date: 07/12/2009

Estimated study completion date

31/12/2010

Contact

Sponsor

EORTC

Principal Investigator(s)

E.J.Th. Rutgers, G.J. van Tienhoven

Study manager

Aleksandra Perić, PhD EORTC, Project Manager

aleksandra.peric@eortc.be
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
www.eortc.be
Tel +32 2 774 16 11
orta@eortc.be

Monitoring

Quality control via dummy runs

Local datamanagement

IKNL

Funding

Funding by KWF

Design

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

Objectives

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 notsubjecting patients with a negative sentinel lymph node to axillary lymph node dissection.

Endpoints

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

Eligibility Criteria

T1,2 (> 5 mm and < 50 mm), N0 M0 Age >=18 Pre-and postmenopausal Female patients

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 20/07/2000

EC

Nederlands Kanker Instituut
Amendments:
Yes
Date Last Amendment: 22/02/2008

Trial Register

NCT00014612

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