Chemotherapy-induced Febrile Neutropenia Clinical Trial
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.
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.
Status | Completed |
Enrollment | 1007 |
Est. completion date | February 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Bendigo | Victoria |
Australia | Research Site | Shepparton | Victoria |
Australia | Research Site | Tweed Heads | New South Wales |
Australia | Research Site | Wodonga | Victoria |
Austria | Research Site | Eggenburg | |
Austria | Research Site | Graz | |
Austria | Research Site | Leoben | |
Austria | Research Site | Vöcklabruck | |
Austria | Research Site | Wien | |
Austria | Research Site | Wien | |
Canada | Research Site | Moncton | New Brunswick |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Sault Ste. Marie | Ontario |
France | Research Site | Alès Cédex | |
France | Research Site | Arras | |
France | Research Site | Besançon Cedex | |
France | Research Site | Brest Cedex 2 | |
France | Research Site | Créteil | |
France | Research Site | Grenoble Cedex 9 | |
France | Research Site | Marseille | |
France | Research Site | Montluçon | |
France | Research Site | Neuilly sur Seine | |
France | Research Site | Nimes Cedex 2 | |
France | Research Site | Pierre Bénite Cedex | |
France | Research Site | Saint Quentin | |
France | Research Site | Toulon Cedex | |
France | Research Site | Villefranche Sur Saone Cedex | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bonn | |
Germany | Research Site | Fulda | |
Germany | Research Site | Mainz | |
Germany | Research Site | Neustadt/Sachsen | |
Germany | Research Site | Rostock | |
Germany | Research Site | Stralsund | |
Germany | Research Site | Twistringen | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Chania | |
Greece | Research Site | Larissa | |
Greece | Research Site | Nea Kifissia, Athens | |
Greece | Research Site | Thessaloniki | |
Greece | Research Site | Thessaloniki | |
Greece | Research Site | Thessaloniki | |
Ireland | Research Site | Cork | |
Ireland | Research Site | Galway | |
Italy | Research Site | Catania | |
Italy | Research Site | Firenze | |
Italy | Research Site | Foggia | |
Italy | Research Site | Monza (MB) | |
Italy | Research Site | Pordenone | |
Italy | Research Site | Reggio Calabria | |
Italy | Research Site | Roma | |
Italy | Research Site | Torino | |
Italy | Research Site | Varese | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Bydgoszcz | |
Poland | Research Site | Elblag | |
Poland | Research Site | Gdynia | |
Poland | Research Site | Lodz | |
Poland | Research Site | Lodz | |
Poland | Research Site | Szczecin | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Wroclaw | |
Romania | Research Site | Braila | |
Romania | Research Site | Brasov | |
Romania | Research Site | Brasov | |
Romania | Research Site | Bucharest | |
Romania | Research Site | Cluj Napoca | |
Romania | Research Site | Cluj-Napoca | |
Romania | Research Site | Focsani | |
Romania | Research Site | Iasi | |
Romania | Research Site | Onesti | |
Romania | Research Site | Oradea | |
Romania | Research Site | Pitesti | |
Romania | Research Site | Suceava | |
Romania | Research Site | Timisoara | |
Romania | Research Site | Timisoara | |
Spain | Research Site | Avila | Castilla León |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Huelva | Andalucía |
Spain | Research Site | La laguna | Canarias |
Spain | Research Site | Malaga | Andalucía |
Spain | Research Site | Palma de Mallorca | Baleares |
Spain | Research Site | Pamplona | Navarra |
Spain | Research Site | Valencia | Comunidad Valenciana |
Spain | Research Site | Valladolid | Castilla León |
Spain | Research Site | Zaragoza | Aragón |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Australia, Austria, Canada, France, Germany, Greece, Ireland, Italy, Poland, Romania, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (prior to participant enrolment) | No |
Primary | 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 | Assessed at Baseline, prior to participant enrolment. | No |
Primary | 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. | At enrolment, prior to chemotherapy initiation | No |
Primary | 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. | At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. | Assessed at baseline, prior to participant enrolment. | No |
Secondary | 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. | Assessed at baseline, prior to participant enrolment. | No |
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 | 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. | Assessed at baseline, prior to participant enrolment. | No |
Secondary | 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. | Assessed at baseline, prior to participant enrolment. | No |
Secondary | 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. | At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
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 | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. | Assessed at Baseline, prior to participant enrolment. | No |
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 | 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. | Assessed at Baseline, prior to participant enrolment. | No |
Secondary | 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. | Assessed at Baseline, prior to participant enrolment. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
Secondary | 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. |
At enrolment, prior to chemotherapy initiation. | No |
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 | 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. | At Baseline and at enrolment, prior to chemotherapy initiation. | No |
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