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 | |||||
| Website | http://www.eortc.org/research_field/clinical-detail/10981/ | ||||
| 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 aleksandra.peric@eortc.be |
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| 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 |
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| Monitoring | Quality control via dummy runs | |||
| Local datamanagement | IKNL | |||
| Funding |
 Funding by KWF |
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| Extra | http://clinicaltrials.gov/ct/show/NCT00014612 | |||
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 not subjecting 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
Main eligibility criteria:
- T1,2 (> 5 mm and < 50 mm), N0 M0
- Age >=18
- Pre-and postmenopausal
- Female patients
Documents (public):
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