N/A
N=1,007
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Chemotherapy-induced Febrile Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT01813721 ↗Enrolled (actual)
1,007
Serious AEs
—
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia — 73.4; 88.3; 41.1; 25.0 percentage of investigators
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia |
73.4; 88.3; 41.1; 25.0; 22.2; 21.5 | — |
| PRIMARY Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) |
88.3; 83.0; 76.2; 73.4; 70.5; 69.9 | — |
| PRIMARY Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor |
39.4; 92.6; 36.2; 17.1; 9.9; 6.9 | — |
| PRIMARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important |
92.6; 72.3; 61.7; 42.9; 39.4; 30.9 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important |
88.7; 79.7; 73.8; 70.5; 69.4; 66.1 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty |
88.4; 78.5; 77.7; 75.5; 73.7; 70.5 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology |
85.4; 90.2; 79.2; 79.4; 77.1; 66.8 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type |
91.9; 84.8; 77.5; 71.8; 75.2; 89.0 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important |
78.6; 67.4; 67.1; 51.4; 36.1; 18.1 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country |
53.2; 60.3; 91.2; 74.5; 79.9; 39.5 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty |
79.8; 78.6; 72.6; 33.3; 69.9; 65.7 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology |
76.6; 76.8; 59.3; 65.2; 57.7; 71.1 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type |
78.1; 73.4; 90.6; 62.4; 68.2; 65.2 | — |
| SECONDARY Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type |
81.4; 64.5; 78.5; 62.6; 75.5; 59.7 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty |
88.5; 82.2; 74.7; 71.4; 68.6; 67.4 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology |
89.6; 87.4; 89.5; 79.6; 73.1; 67.3 | — |
| SECONDARY Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type |
91.2; 87.0; 87.5; 78.3; 73.1; 62.9 | — |
| SECONDARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country |
81.4; 96.3; 98.2; 88.3; 67.8; 61.4 | — |
| SECONDARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty |
93.1; 93.6; 72.6; 81.4; 71.9; 27.5 | — |
| SECONDARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology |
91.5; 92.6; 59.1; 76.6; 55.7; 60.1 | — |
| SECONDARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type |
95.4; 92.7; 91.9; 86.1; 66.2; 81.6 | — |
| SECONDARY Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type |
93.8; 85.8; 90.6; 80.5; 64.9; 75.9 | — |
| SECONDARY Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP |
82.0 | — |
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 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest.
Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited.
This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01813721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.