A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2014-09-30

Brief Summary

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The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.

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Detailed Description

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This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung).

This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.

Conditions

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Breast Cancer Non-Small Cell Lung Cancer Ovarian Cancer Small Cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
* These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Exclusion Criteria

\- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No