CompletedNot Applicable

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

Australia, Austria1,007 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia

Timeframe: Baseline (prior to participant enrolment)

Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)

Timeframe: Assessed at Baseline, prior to participant enrolment.

Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor

Timeframe: At enrolment, prior to chemotherapy initiation

Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important

Timeframe: At enrolment, prior to chemotherapy initiation.

Trial details

NCT IDNCT01813721

SponsorAmgen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-12

Results submitted2014-12-04

View on ClinicalTrials.gov More Chemotherapy-induced Febrile Neutropenia trials