Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

NCT01813721 | Completed Results

• 1 other identifier: 20110146
• Study Type: observational
• Target: 1,007
• Locations: 10 countries
• Sites: 86

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.

Conditions

Chemotherapy-induced Febrile Neutropenia

Keywords

NHL; Breast Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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)

• 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.

• 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

• 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.

Secondary Outcomes (19)

• Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important

  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

  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

  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

  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

  At enrolment, prior to chemotherapy initiation.

Study Arms (1)

Group 1

All patients enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (90)

Research Site

Tweed Heads, New South Wales, 2485, Australia

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Bendigo, Victoria, 3550, Australia

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Shepparton, Victoria, 3630, Australia

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Wodonga, Victoria, 3690, Australia

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Eggenburg, 3730, Austria

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Graz, 8036, Austria

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Leoben, 8700, Austria

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Vienna, 1030, Austria

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Vienna, 1090, Austria

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Vöcklabruck, 4840, Austria

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Moncton, New Brunswick, E1C 6Z8, Canada

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Sault Ste. Marie, Ontario, P6B 0A8, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Alès Cédex, 30103, France

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Arras, 62000, France

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Besançon, 25030, France

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Brest, 29609, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Marseille, 13009, France

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Montluçon, 03100, France

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Neuilly-sur-Seine, 92202, France

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Nîmes, 30900, France

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Pierre-Bénite, 69495, France

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Saint-Quentin, 02321, France

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Toulon, 83056, France

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Villefranche-sur-Saône, 69400, France

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Berlin, 10317, Germany

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Bonn, 53111, Germany

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Fulda, 36043, Germany

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Mainz, 55131, Germany

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Neustadt/Sachsen, 01844, Germany

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Rostock, 18107, Germany

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Stralsund, 18435, Germany

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Twistringen, 27239, Germany

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Athens, 11522, Greece

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Athens, 11525, Greece

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Athens, 11527, Greece

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Athens, 18547, Greece

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Chania, 73300, Greece

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Larissa, 41110, Greece

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Nea Kifissia, Athens, 14564, Greece

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Thessaloniki, 54636, Greece

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Thessaloniki, 54645, Greece

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Thessaloniki, 57010, Greece

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Cork, Ireland

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Galway, Ireland

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Catania, 95122, Italy

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Florence, 50134, Italy

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Foggia, 71100, Italy

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Monza (MB), 20900, Italy

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Pordenone, 33170, Italy

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Reggio Calabria, 89124, Italy

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Roma, 00128, Italy

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Torino, 10125, Italy

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Varese, 21100, Italy

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Bialystok, 15-027, Poland

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Bydgoszcz, 85-796, Poland

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Elblag, 82-300, Poland

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Gdynia, 81-519, Poland

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Lodz, 90-722, Poland

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Lodz, 93-509, Poland

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Szczecin, 71-730, Poland

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Warsaw, 02-781, Poland

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Wroclaw, 50-981, Poland

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Brasov, 500052, Romania

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Brasov, 500152, Romania

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Brăila, 810325, Romania

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Bucharest, 030171, Romania

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Cluj-Napoca, 400006, Romania

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Cluj-Napoca, 400352, Romania

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Focşani, 620165, Romania

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Iași, 700483, Romania

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Onești, 601048, Romania

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Oradea, 410469, Romania

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Piteşti, 110084, Romania

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Suceava, 720237, Romania

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Timișoara, 300167, Romania

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Timișoara, 300239, Romania

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Huelva, Andalusia, 21005, Spain

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Málaga, Andalusia, 29010, Spain

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Zaragoza, Aragon, 50009, Spain

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Palma de Mallorca, Balearic Islands, 07198, Spain

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San Cristóbal de La Laguna, Canary Islands, 38320, Spain

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Ávila, Castille and León, 05004, Spain

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Valladolid, Castille and León, 47005, Spain

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Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08035, Spain

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Pamplona, Navarre, 31008, Spain

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Valencia, Valencia, 46015, Spain

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Related Publications (2)

• 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.

  PMID: 26315712 BACKGROUND

• 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.

  PMID: 25810005 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: March 19, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 15, 2017
• Results First Posted: December 24, 2014

Record last verified: 2017-02

Locations

IE (2); IT (9); PL (9); FR (14); AU (6); RO (14); ES (11); DE (8); CA (3); GR (10)