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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01813721




Registration number
NCT01813721
Ethics application status
Date submitted
8/01/2013
Date registered
19/03/2013
Date last updated
15/03/2017

Titles & IDs
Public title
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Scientific 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.
Secondary ID [1] 0 0
20110146
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced Febrile Neutropenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group 1 - All patients enrolled
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Timepoint [1] 0 0
Baseline (prior to participant enrolment)
Primary outcome [2] 0 0
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Timepoint [2] 0 0
Assessed at Baseline, prior to participant enrolment.
Primary outcome [3] 0 0
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Timepoint [3] 0 0
At enrolment, prior to chemotherapy initiation
Primary outcome [4] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Timepoint [4] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [1] 0 0
Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
Timepoint [1] 0 0
Assessed at baseline, prior to participant enrolment.
Secondary outcome [2] 0 0
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
Timepoint [2] 0 0
Assessed at baseline, prior to participant enrolment.
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Assessed at baseline, prior to participant enrolment.
Secondary outcome [4] 0 0
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
Timepoint [4] 0 0
Assessed at baseline, prior to participant enrolment.
Secondary outcome [5] 0 0
Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
Timepoint [5] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [6] 0 0
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country
Timepoint [6] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [7] 0 0
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty
Timepoint [7] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [9] 0 0
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type
Timepoint [9] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [10] 0 0
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type
Timepoint [10] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [11] 0 0
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Timepoint [11] 0 0
Assessed at Baseline, prior to participant enrolment.
Secondary outcome [12] 0 0
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
Timepoint [12] 0 0
Assessed at Baseline, prior to participant enrolment.
Secondary outcome [13] 0 0
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Timepoint [13] 0 0
Assessed at Baseline, prior to participant enrolment.
Secondary outcome [14] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Timepoint [14] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [15] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Timepoint [15] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [16] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology
Timepoint [16] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [17] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Timepoint [17] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [18] 0 0
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Timepoint [18] 0 0
At enrolment, prior to chemotherapy initiation.
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
At Baseline and at enrolment, prior to chemotherapy initiation.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
1007
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Tweed Heads
Recruitment hospital [2] 0 0
Research Site - Bendigo
Recruitment hospital [3] 0 0
Research Site - Shepparton
Recruitment hospital [4] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
3550 - Bendigo
Recruitment postcode(s) [3] 0 0
3630 - Shepparton
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Eggenburg
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Leoben
Country [4] 0 0
Austria
State/province [4] 0 0
Vöcklabruck
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Canada
State/province [6] 0 0
New Brunswick
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
France
State/province [9] 0 0
Alès Cédex
Country [10] 0 0
France
State/province [10] 0 0
Arras
Country [11] 0 0
France
State/province [11] 0 0
Besançon Cedex
Country [12] 0 0
France
State/province [12] 0 0
Brest Cedex 2
Country [13] 0 0
France
State/province [13] 0 0
Créteil
Country [14] 0 0
France
State/province [14] 0 0
Grenoble Cedex 9
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
France
State/province [16] 0 0
Montluçon
Country [17] 0 0
France
State/province [17] 0 0
Neuilly sur Seine
Country [18] 0 0
France
State/province [18] 0 0
Nimes Cedex 2
Country [19] 0 0
France
State/province [19] 0 0
Pierre Benite Cedex
Country [20] 0 0
France
State/province [20] 0 0
Saint Quentin
Country [21] 0 0
France
State/province [21] 0 0
Toulon Cedex
Country [22] 0 0
France
State/province [22] 0 0
Villefranche Sur Saone Cedex
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Bonn
Country [25] 0 0
Germany
State/province [25] 0 0
Fulda
Country [26] 0 0
Germany
State/province [26] 0 0
Mainz
Country [27] 0 0
Germany
State/province [27] 0 0
Neustadt/Sachsen
Country [28] 0 0
Germany
State/province [28] 0 0
Rostock
Country [29] 0 0
Germany
State/province [29] 0 0
Stralsund
Country [30] 0 0
Germany
State/province [30] 0 0
Twistringen
Country [31] 0 0
Greece
State/province [31] 0 0
Athens
Country [32] 0 0
Greece
State/province [32] 0 0
Chania
Country [33] 0 0
Greece
State/province [33] 0 0
Larissa
Country [34] 0 0
Greece
State/province [34] 0 0
Nea Kifissia, Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Thessaloniki
Country [36] 0 0
Ireland
State/province [36] 0 0
Cork
Country [37] 0 0
Ireland
State/province [37] 0 0
Galway
Country [38] 0 0
Italy
State/province [38] 0 0
Catania
Country [39] 0 0
Italy
State/province [39] 0 0
Firenze
Country [40] 0 0
Italy
State/province [40] 0 0
Foggia
Country [41] 0 0
Italy
State/province [41] 0 0
Monza (MB)
Country [42] 0 0
Italy
State/province [42] 0 0
Pordenone
Country [43] 0 0
Italy
State/province [43] 0 0
Reggio Calabria
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Torino
Country [46] 0 0
Italy
State/province [46] 0 0
Varese
Country [47] 0 0
Poland
State/province [47] 0 0
Bialystok
Country [48] 0 0
Poland
State/province [48] 0 0
Bydgoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Elblag
Country [50] 0 0
Poland
State/province [50] 0 0
Gdynia
Country [51] 0 0
Poland
State/province [51] 0 0
Lodz
Country [52] 0 0
Poland
State/province [52] 0 0
Szczecin
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Poland
State/province [54] 0 0
Wroclaw
Country [55] 0 0
Romania
State/province [55] 0 0
Braila
Country [56] 0 0
Romania
State/province [56] 0 0
Brasov
Country [57] 0 0
Romania
State/province [57] 0 0
Bucharest
Country [58] 0 0
Romania
State/province [58] 0 0
Cluj Napoca
Country [59] 0 0
Romania
State/province [59] 0 0
Cluj-Napoca
Country [60] 0 0
Romania
State/province [60] 0 0
Focsani
Country [61] 0 0
Romania
State/province [61] 0 0
Iasi
Country [62] 0 0
Romania
State/province [62] 0 0
Onesti
Country [63] 0 0
Romania
State/province [63] 0 0
Oradea
Country [64] 0 0
Romania
State/province [64] 0 0
Pitesti
Country [65] 0 0
Romania
State/province [65] 0 0
Suceava
Country [66] 0 0
Romania
State/province [66] 0 0
Timisoara
Country [67] 0 0
Spain
State/province [67] 0 0
Andalucía
Country [68] 0 0
Spain
State/province [68] 0 0
Aragón
Country [69] 0 0
Spain
State/province [69] 0 0
Baleares
Country [70] 0 0
Spain
State/province [70] 0 0
Canarias
Country [71] 0 0
Spain
State/province [71] 0 0
Castilla León
Country [72] 0 0
Spain
State/province [72] 0 0
Cataluña
Country [73] 0 0
Spain
State/province [73] 0 0
Comunidad Valenciana
Country [74] 0 0
Spain
State/province [74] 0 0
Navarra

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/study/NCT01813721
Trial related presentations / 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.
Lyman 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01813721