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 |
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| Monitoring | No monitoring | |||
| Local datamanagement | ||||
| Funding |
 Funding by KWF |
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| 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):
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