Various G-CSF Regimens to Prevent Infection During Chemotherapy
Primary G-CSF Prophylaxis During the First Two Cycles Only or Throughout All Chemotherapy Cycles in Breast Cancer Patients at Risk of Febrile Neutropenia
3 other identifiers
interventional
172
1 country
21
Brief Summary
The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious \[1-3\]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia. Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia. The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear. So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jan 2008
Typical duration for phase_3 breast-cancer
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2007
CompletedFirst Posted
Study publicly available on registry
September 27, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 6, 2019
November 1, 2019
1.9 years
September 25, 2007
November 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of febrile neutropenia episodes costs per treatment arm
18 weeks (all chemotherapy cycles)
Secondary Outcomes (1)
Febrile neutropenia rates per cycle number. Other haematological and non-haematological toxicities. Number of chemotherapy cycles delivered. Dose and dose-intensity of chemotherapy. Disease progression. Number of toxic deaths per treatment arm.
18 weeks (all chemotherapy cycles)
Study Arms (2)
A
ACTIVE COMPARATORPegfilgrastim during all 6 cycles of chemotherapy
B
EXPERIMENTALPegfilgrastim during the first two cycles of chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Breast cancer patients ≥18 years.
- Indication for 3-weekly chemotherapy.
- Considered fit enough to receive chemotherapy, with adequate renal and hepatic function.
- Planned a chemotherapy regime in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
- Regimes with \>20% risk of febrile neutropenia:
- e.g. TAC (docetaxel, adriamycin, cyclophosphamide)
- AT (adriamycin, docetaxel)
- Regimes with 10-20% risk of febrile neutropenia (e.g. AC, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of ≥1 patient risk factor (\>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue
- Prior chemotherapy
- ECOG performance status of 2 or more, grade 2 or higher liver function abnormalities).
- That is, patients starting with docetaxel as second part of FEC-D are eligible for the last 3 docetaxel cycles, if there is an increased risk of febrile neutropenia, e.g. by elderly age.
- Able to comply with the protocol.
- Written informed consent obtained prior to any study specific screening.
You may not qualify if:
- Active uncontrolled infection.
- Inadequate renal or hepatic function.
- Any evidence or history of hypersensitivity or other contraindications to G-CSF medication.
- Not recovered from acute toxicities of prior therapies.
- Absolute neutrophil count (ANC) \<1.5 x 109/l, not caused by bone marrow involvement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Ziekenhuis Rijnstate, Alysis
Arnhem, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Diaconessenhuis Leiden
Leiden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
University Hospital Maastricht
Maastricht, 6202 AZ, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Erasmus MC - Daniel den Hoed
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Orbis Medisch Centrum
Sittard, Netherlands
Mesos Medisch Centrum
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Ziekenhuis Zevenaar, Alysis
Zevenaar, Netherlands
Related Publications (1)
Aarts MJ, Grutters JP, Peters FP, Mandigers CM, Dercksen MW, Stouthard JM, Nortier HJ, van Laarhoven HW, van Warmerdam LJ, van de Wouw AJ, Jacobs EM, Mattijssen V, van der Rijt CC, Smilde TJ, van der Velden AW, Temizkan M, Batman E, Muller EW, van Gastel SM, Joore MA, Borm GF, Tjan-Heijnen VC. Cost effectiveness of primary pegfilgrastim prophylaxis in patients with breast cancer at risk of febrile neutropenia. J Clin Oncol. 2013 Dec 1;31(34):4283-9. doi: 10.1200/JCO.2012.48.3644. Epub 2013 Oct 28.
PMID: 24166522DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivianne CG Tjan-Heijnen, MD PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr.
Study Record Dates
First Submitted
September 25, 2007
First Posted
September 27, 2007
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2016
Last Updated
November 6, 2019
Record last verified: 2019-11