Studieoverzicht - 2008-01 2-2-6 G-CSF
| Number | 2008-01 2-2-6 G-CSF | ||||
| Nickname | 2-2-6 G-CSF | ||||
| Status | Closed | Date: 15-12-2009 | |||
| Inclusion closed | |||||
| Other study number(s) | ZonMW | ||||
| Participating parties/groups | |||||
| Full title | Primary G-CSF prophylaxis during the first two cycles only or throughout all chemotherapy cycles in breast cancer patients at risk of febrile neutropenia. Prospective randomised phase III study and HTA methodology study | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥ 18 | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | Any HER2, any HR | ||||
| Target sample size | 230 | ||||
| Actual accrual | 163 | Date: 15-12-2009 | |||
| Estimated study completion date | 15-12-2009 | ||||
| CCMO approval | Date: | Nr: | |||
| EudraCT nr. | 2007-005402-53 | ||||
| Trial Register | NCT00536081 | ||||
| METC approval | Yes | Date: | METC: Academisch Ziekenhuis Maastricht | Nr: | |
| Amendments | No | Date: | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | MUMC | ||||
| Principal Investigator(s) | V.C.G. Tjan-Heijnen | |||
| Study manager | ||||
| Central datamanagement and randomization | Trialoffice IKO Radboud University Nijmegen, Medical Centre PO Box 9101, HP 485 6500 HB Nijmegen Tel 024 361 68 37 Fax 024 361 90 80 E-mail trialiko@onco.umcn.nl |
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| Monitoring | ||||
| Local datamanagement | ||||
| Funding |
 Funding by ZON-MW |
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| Extra | ||||
Design:
Randomization:
Arm A (standard arm): 6 cycles of doxorubicin-docetaxel containing chemotherapy with G-CSF support
in cycles 1 through 6 versus
Arm B (experimental arm): 6 cycles of doxorubicin-docetaxel containing chemotherapy with G-CSF
support only in cycles 1 and 2.
Objectives:
To determine the most cost-effective strategy of primary G-CSF prophylaxis
To determine the most cost-effective strategy of primary G-CSF prophylaxis
Endpoints:
Primary clinical endpoint:
- Incidence of febrile neutropenia
The primary economic endpoint:
- costs per treatment arm
Secondary endpoints:
- QoL
- Chemotherapy dose
- Dose-intensity
Main eligibility criteria:
Breast cancer patients who will be treated with doxorubicin-docetaxel chemotherapy, 3-weekly chemotherapy, being at risk of FN according to criteria of international guidelines
Documents (public):
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