Status:
COMPLETED
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Lead Sponsor:
Amgen
Conditions:
Chemotherapy-induced Febrile Neutropenia
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investig...
Detailed Description
Although a formal hypothesis will not be tested in this observational study, it is hypothesized that the clinical risk factors ranked as the most important when conducting FN risk assessments by inves...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Any stage NHL, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or breast cancer initiating a new chemotherapy course
- Scheduled to receive one of the permitted standard dose chemotherapy regimens with an estimated intermediate (10%-20%) FN risk according to published data or guidelines (planned dose modifications +/-10% are allowable).
- Before any study-specific procedure, the appropriate written informed consent must be obtained where this is required by local regulations
Exclusion
- Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency (EMA) or competent authority for any indication,
- Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated)
- Prior stem-cell transplantation (includes bone marrow transplantation)
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1007 Patients enrolled
Trial Details
Trial ID
NCT01813721
Start Date
December 1 2012
End Date
December 1 2013
Last Update
March 15 2017
Active Locations (90)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Tweed Heads, New South Wales, Australia, 2485
2
Research Site
Bendigo, Victoria, Australia, 3550
3
Research Site
Shepparton, Victoria, Australia, 3630
4
Research Site
Wodonga, Victoria, Australia, 3690