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

NCT ID: NCT01813721

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1007 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

All patients enrolled

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Any stage NHL, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or breast cancer initiating a new chemotherapy course
• Scheduled to receive one of the permitted standard dose chemotherapy regimens with an estimated intermediate (10%-20%) FN risk according to published data or guidelines (planned dose modifications +/-10% are allowable).
• Before any study-specific procedure, the appropriate written informed consent must be obtained where this is required by local regulations

Exclusion Criteria

• Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency (EMA) or competent authority for any indication,
• Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated)
• Prior stem-cell transplantation (includes bone marrow transplantation)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Tweed Heads, New South Wales, Australia

Research Site

Bendigo, Victoria, Australia

Research Site

Shepparton, Victoria, Australia

Research Site

Wodonga, Victoria, Australia

Research Site

Eggenburg, , Austria

Research Site

Graz, , Austria

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Leoben, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vöcklabruck, , Austria

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Moncton, New Brunswick, Canada

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Sault Ste. Marie, Ontario, Canada

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Montreal, Quebec, Canada

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Alès Cédex, , France

Research Site

Arras, , France

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Besançon, , France

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Brest, , France

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Créteil, , France

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Grenoble, , France

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Marseille, , France

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Montluçon, , France

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Neuilly-sur-Seine, , France

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Nîmes, , France

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Pierre-Bénite, , France

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Saint-Quentin, , France

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Toulon, , France

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Villefranche-sur-Saône, , France

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Berlin, , Germany

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Bonn, , Germany

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Fulda, , Germany

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Mainz, , Germany

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Neustadt/Sachsen, , Germany

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Rostock, , Germany

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Stralsund, , Germany

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Twistringen, , Germany

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Chania, , Greece

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Larissa, , Greece

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Nea Kifissia, Athens, , Greece

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Thessaloniki, , Greece

Research Site

Thessaloniki, , Greece

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Thessaloniki, , Greece

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Cork, , Ireland

Research Site

Galway, , Ireland

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Catania, , Italy

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Florence, , Italy

Research Site

Foggia, , Italy

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Monza (MB), , Italy

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Pordenone, , Italy

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Reggio Calabria, , Italy

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Roma, , Italy

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Torino, , Italy

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Varese, , Italy

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Elblag, , Poland

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Gdynia, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Brasov, , Romania

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Brasov, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

Research Site

Focşani, , Romania

Research Site

Iași, , Romania

Research Site

Onești, , Romania

Research Site

Oradea, , Romania

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Piteşti, , Romania

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Suceava, , Romania

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Timișoara, , Romania

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Timișoara, , Romania

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Huelva, Andalusia, Spain

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Málaga, Andalusia, Spain

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Zaragoza, Aragon, Spain

Research Site

Palma de Mallorca, Balearic Islands, Spain

Research Site

San Cristóbal de La Laguna, Canary Islands, Spain

Research Site

Ávila, Castille and León, Spain

Research Site

Valladolid, Castille and León, Spain

Research Site

Barcelona, Catalonia, Spain

Research Site

Barcelona, Catalonia, Spain

Research Site

Pamplona, Navarre, Spain

Research Site

Valencia, Valencia, Spain

Countries

Australia; Austria; Canada; France; Germany; Greece; Ireland; Italy; Poland; Romania; Spain

References

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.

Reference Type: BACKGROUND

PMID: 26315712 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25810005 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20110146

Identifier Type: -

Identifier Source: org_study_id