Studieoverzicht - 2006-02 OMEGA

 
Number 2006-02 OMEGA
Nickname OMEGA
Status Closed Date: 01-09-2011
Inclusion closed
Other study number(s) CKTO 2006-09
Participating parties/groups
Full title A randomized, open-label phase III study of first-line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a clinical geriatric assessment.
Phase and type Randomized Phase III
Age ≥ 65
Menopausal status Postmenopausal
Indication Advanced/metastatic
Subindication Any HER2, any HR
Target sample size 154
Actual accrual 78 Date: 01-09-2011
Estimated study completion date 31-12-2011
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2006-002046-10
Trial Register ISRCTN11114726
METC approval Yes Date: 14-07-2006 METC: METC Noord-Holland Nr: M06-015
Amendments Yes Date:
KWF-CKS approval Yes Date: 12-07-2006 Nr: CKTO 2006-09
News item
Website http://www.boogstudycenter.nl
Sponsor Borstkanker Onderzoek Groep
Principal Investigator(s) C.M.J.C Seynaeve, C.H. Smorenburg, M. Wymenga
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization IKNL locatie Amsterdam, Trialbureau
PO Box 9236
1006 AE Amsterdam
Email amsterdam.trialbureau@iknl.nl
Tel 020 3462544
Fax 020 3462597
Monitoring No monitoring
Local datamanagement
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

Randomization:
Arm A: Pegylated liposomal doxorubicin
Arm B: Oral capecitabine

Objectives:
Endpoints:

Primary endpoints:

  • Progression free survival


Secondary endpoints:

  • Response (CR, PR, SD)
  • Clinical benefit
  • Overall survival
  • The relation of respons and toxicity
  • The value of geriatric assessment (CGA)
Main eligibility criteria:
  • Female >=65 years of age, with proven metastatic breast cancer, eligible for first-line chemotherapy.
  • Evaluable (non-measurable) or measurable disease.  
  • ECOG performance score < 3.
  • Compliant with filling out questionnaires in the Dutch language.
Documents (public):
Documents (protected):
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