Chemotherapy-induced Febrile NeutropeniaNCT01813721
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
An observational study of Chemotherapy-induced Febrile Neutropenia, run by Amgen at 90 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Febrile Neutropenia
- How many people
- 1,007 participants
- Where
- 90 sitesin 11 countries
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects will have NHL, breast or lung cancer and be due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol (those with a documented intermediate FN risk of 10-20%). Subjects will be prospectively and sequentially identified by approximately 150-200 investigators during their clinics distribututed in 11 countries.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
90 sites in 11 countries.
90 sites in 11 countries
France14 sites
Research Site
Alès Cédex, 30103
Research Site
Arras, 62000
Research Site
Besançon, 25030
Research Site
Brest, 29609
Research Site
Créteil, 94010
Research Site
Grenoble, 38043
Research Site
Marseille, 13009
Research Site
Montluçon, 03100
Research Site
Neuilly-sur-Seine, 92202
Research Site
Nîmes, 30900
Research Site
Pierre-Bénite, 69495
Research Site
Saint-Quentin, 02321
Research Site
Toulon, 83056
Research Site
Villefranche-sur-Saône, 69400
Romania14 sites
Research Site
Brăila, 810325
Research Site
Brasov, 500052
Research Site
Brasov, 500152
Research Site
Bucharest, 030171
Research Site
Cluj-Napoca, 400006
Research Site
Cluj-Napoca, 400352
Research Site
Focşani, 620165
Research Site
Iași, 700483
Research Site
Onești, 601048
Research Site
Oradea, 410469
Research Site
Piteşti, 110084
Research Site
Suceava, 720237
Research Site
Timișoara, 300167
Research Site
Timișoara, 300239
Spain11 sites
Research Site
Ávila, Castille and León, 05004
Research Site
Barcelona, Catalonia, 08003
Research Site
Barcelona, Catalonia, 08035
Research Site
Huelva, Andalusia, 21005
Research Site
Málaga, Andalusia, 29010
Research Site
Palma de Mallorca, Balearic Islands, 07198
Research Site
Pamplona, Navarre, 31008
Research Site
San Cristóbal de La Laguna, Canary Islands, 38320
Research Site
Valencia, Valencia, 46015
Research Site
Valladolid, Castille and León, 47005
Research Site
Zaragoza, Aragon, 50009
Greece10 sites
Research Site
Athens, 11522
Research Site
Athens, 11525
Research Site
Athens, 11527
Research Site
Athens, 18547
Research Site
Chania, 73300
Research Site
Larissa, 41110
Research Site
Nea Kifissia, Athens, 14564
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 54645
Research Site
Thessaloniki, 57010
Italy9 sites
Research Site
Catania, 95122
Research Site
Florence, 50134
Research Site
Foggia, 71100
Research Site
Monza (MB), 20900
Research Site
Pordenone, 33170
Research Site
Reggio Calabria, 89124
Research Site
Roma, 00128
Research Site
Torino, 10125
Research Site
Varese, 21100
Poland9 sites
Research Site
Bialystok, 15-027
Research Site
Bydgoszcz, 85-796
Research Site
Elblag, 82-300
Research Site
Gdynia, 81-519
Research Site
Lodz, 90-722
Research Site
Lodz, 93-509
Research Site
Szczecin, 71-730
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 50-981
Germany8 sites
Research Site
Berlin, 10317
Research Site
Bonn, 53111
Research Site
Fulda, 36043
Research Site
Mainz, 55131
Research Site
Neustadt/Sachsen, 01844
Research Site
Rostock, 18107
Research Site
Stralsund, 18435
Research Site
Twistringen, 27239
Austria6 sites
Research Site
Eggenburg, 3730
Research Site
Graz, 8036
Research Site
Leoben, 8700
Research Site
Vienna, 1030
Research Site
Vienna, 1090
Research Site
Vöcklabruck, 4840
Australia4 sites
Research Site
Bendigo, Victoria, 3550
Research Site
Shepparton, Victoria, 3630
Research Site
Tweed Heads, New South Wales, 2485
Research Site
Wodonga, Victoria, 3690
Canada3 sites
Research Site
Moncton, New Brunswick, E1C 6Z8
Research Site
Montreal, Quebec, H2W 1T8
Research Site
Sault Ste. Marie, Ontario, P6B 0A8
About this study
Official title: Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.
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.
Read more
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.
Read the 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 investigators are aligned with international guidelines and published data. Also, that the investigator's decision to treat with G-CSF PP is influenced by clinical and non-clinical risk factors (such as distance from site, estimated subject compliance, and access to fully reimbursed G-CSF).
Study Design: Prior to identifying eligible subjects, Investigators will be registered and will record baseline information. During this Baseline Investigator Assessment investigators will be provided with two lists of risk factors. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not (this list will also contain non clinical factors). They will also record their own FN risk intervention threshold, which is the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice.
Investigators will then prospectively and sequentially identify eligible subjects with NHL, breast or lung cancer who are due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol. The permitted chemotherapy regimens have an estimated intermediate FN risk (10%-20%) documented in published data and/or international guidelines.
For each enrolled subject, Investigators will complete a Subject Assessment prior to the start of their chemotherapy. They will be provided with the same two lists of risk factors as in the Baseline Assessment and asked to complete them based on each specific subject. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not. They will also document their final estimated FN risk score as a percentage based on the subject's medical history and standard of care (SOC) assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP will be administered. Investigators will record which type of G-CSF they plan to use if one will be used.
End of Study for a subject will occur once these activities have been completed, and a prescription for the first cycle of chemotherapy has been written. The subject data collected will only be historical subject information and laboratory data from SOC assessments performed prior to beginning chemotherapy treatment. No data will be collected after the initiation of chemotherapy.
The approach to the statistical analysis will be generally descriptive in nature. The primary analysis will be conducted at two levels; investigator level and the subject level. It is expected that the opinions of investigators at a single site (that is, a department within a cancer treatment centre) will be correlated. Also, that the opinions about subjects from a single investigator will be more alike than subjects of other investigators; adjustments will be made in the analyses to account for this. Confidence intervals for the investigator level analysis and the subject level data will obtained from Multi-level Modelling (MLM) to allow for the expected intra-site and intra-investigator correlation of investigators within sites and subjects within investigator. In general, categorical data will be summarised by the number and percentage of subjects in each category. Continuous data will be summarised by mean, standard deviation, median, lower and upper quartiles, minimum and maximum values. Two-sided exact 95% confidence intervals (obtained using MLM) will be presented, where appropriate.
- Conditions
- Chemotherapy-induced Febrile Neutropenia
- Keywords
- NHL, Breast Cancer, Lung Cancer
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All patients enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Measured: Baseline (prior to participant enrolment)
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group
Measured: Assessed at Baseline, prior to participant enrolment.
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Measured: At enrolment, prior to chemotherapy initiation
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Secondary outcomes (19)
Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Measured: Assessed at baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.
Measured: Assessed at baseline, prior to participant enrolment.
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
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
Measured: Assessed at baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
Measured: Assessed at baseline, prior to participant enrolment.
Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
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
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.
Measured: Assessed at Baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Measured: Assessed at Baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Measured: Assessed at Baseline, prior to participant enrolment.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group.
Measured: At enrolment, prior to chemotherapy initiation.
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
At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.
Measured: At Baseline and at enrolment, prior to chemotherapy initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813721
- Sponsor's protocol ID
- 20110146
- Status last verified
- Feb 2017
- First submitted
- 8 Jan 2013
- Last updated
- 15 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Freyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28.
PubMed 26315712Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23.
PubMed 25810005
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.
- ClinicalTrials.gov ID
- NCT01813721
- Acronym / sponsor ID
- 20110146
- Conditions
- Chemotherapy-induced Febrile Neutropenia
- Keywords
- NHL, Breast Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Posted 24 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 investigators are aligned with international guidelines and published data. Also, that the investigator's decision to treat with G-CSF PP is influenced by clinical and non-clinical risk factors (such as distance from site, estimated subject compliance, and access to fully reimbursed G-CSF).
Study Design: Prior to identifying eligible subjects, Investigators will be registered and will record baseline information. During this Baseline Investigator Assessment investigators will be provided with two lists of risk factors. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not (this list will also contain non clinical factors). They will also record their own FN risk intervention threshold, which is the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice.
Investigators will then prospectively and sequentially identify eligible subjects with NHL, breast or lung cancer who are due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol. The permitted chemotherapy regimens have an estimated intermediate FN risk (10%-20%) documented in published data and/or international guidelines.
For each enrolled subject, Investigators will complete a Subject Assessment prior to the start of their chemotherapy. They will be provided with the same two lists of risk factors as in the Baseline Assessment and asked to complete them based on each specific subject. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not. They will also document their final estimated FN risk score as a percentage based on the subject's medical history and standard of care (SOC) assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP will be administered. Investigators will record which type of G-CSF they plan to use if one will be used.
End of Study for a subject will occur once these activities have been completed, and a prescription for the first cycle of chemotherapy has been written. The subject data collected will only be historical subject information and laboratory data from SOC assessments performed prior to beginning chemotherapy treatment. No data will be collected after the initiation of chemotherapy.
The approach to the statistical analysis will be generally descriptive in nature. The primary analysis will be conducted at two levels; investigator level and the subject level. It is expected that the opinions of investigators at a single site (that is, a department within a cancer treatment centre) will be correlated. Also, that the opinions about subjects from a single investigator will be more alike than subjects of other investigators; adjustments will be made in the analyses to account for this. Confidence intervals for the investigator level analysis and the subject level data will obtained from Multi-level Modelling (MLM) to allow for the expected intra-site and intra-investigator correlation of investigators within sites and subjects within investigator. In general, categorical data will be summarised by the number and percentage of subjects in each category. Continuous data will be summarised by mean, standard deviation, median, lower and upper quartiles, minimum and maximum values. Two-sided exact 95% confidence intervals (obtained using MLM) will be presented, where appropriate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –All patients enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will have NHL, breast or lung cancer and be due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol (those with a documented intermediate FN risk of 10-20%). Subjects will be prospectively and sequentially identified by approximately 150-200 investigators during their clinics distribututed in 11 countries.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Time frame: Baseline (prior to participant enrolment)
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Time frame: Assessed at Baseline, prior to participant enrolment.
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Time frame: At enrolment, prior to chemotherapy initiation
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Time frame: At enrolment, prior to chemotherapy initiation.
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
19 secondary outcomes
Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
Time frame: Assessed at baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
Time frame: Assessed at baseline, prior to participant enrolment.
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
Time frame: Assessed at baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
Time frame: Assessed at baseline, prior to participant enrolment.
Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty
Time frame: At enrolment, prior to chemotherapy initiation.
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
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Time frame: Assessed at Baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
Time frame: Assessed at Baseline, prior to participant enrolment.
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Time frame: Assessed at Baseline, prior to participant enrolment.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Time frame: At enrolment, prior to chemotherapy initiation.
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Time frame: At enrolment, prior to chemotherapy initiation.
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
Time frame: At Baseline and at enrolment, prior to chemotherapy initiation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26315712Freyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28.
- Derived from this study: PubMed 25810005Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
90 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Febrile Neutropenia, run by Amgen at 90 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in France, Romania, Spain, Greece, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia (time frame: Baseline (prior to participant enrolment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01813721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.