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Study Complete
Sponsor ID
20060445

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

Sponsor ID
20060445
Clinicaltrials.gov ID
NCT00883181
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
pegfilgrastim
Type
Observational
Masking
N/A
Enrollment
1370
Additional Study Details

Protocol Summary

Primary Outcome Measures

To describe incidence of Febrile Neutropenia (FN) based on Granulocyte Colony Stimulating Factor (G-CSF) (primary, secondary or no usage) use in subjects receiving myelotoxic chemotherapy.

Timeframe: The duration of the G-CSF use

Secondary Outcome Measures

To describe the management of patients who are receiving myelotoxic chemotherapy including G-CSF use, ESA use, anti-infective use, transfusions and hospitalisations

Timeframe: The duration of the chemotherapy plus the five years of long term follow up data

To describe toxicities including febrile neutropenia and anemia

Timeframe: The duration of the chemotherapy

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Breast Cancer
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  • Lung Cancer - Non-Small Cell
  • Ovarian Cancer
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    Nov 2006 - Oct 2009
    Inclusion and Exclusion Criteria
    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).