Clinical Trial: Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.

Brief Summary: The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.

Detailed Summary:
Sponsor: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncologí

Current Primary Outcome: Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of serious adverse events [ Time Frame: 6 months ]
  • Analyze costs to treat febrile neutropenia and neutropenia grade 3/4 [ Time Frame: 6 months ]
  • Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment [ Time Frame: 6 months ]
    A Cox proportional hazards regression will be used to evaluate the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during chemotherapy treatment.
  • Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance [ Time Frame: 6 months ]
    The impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance (yes/no) will be evaluated using a chi-square test.


Original Secondary Outcome:

  • Occurrence of serious adverse events [ Time Frame: 6 months ]
  • Analyze costs to treat febrile neutropenia and neutropenia grade 3/4 [ Time Frame: 6 months ]
  • Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment [ Time Frame: 6 months ]
  • Study the occurrence of febrile neutropenia and neutropenia grade 3/4 vs fulfillment of chemotherapy treatment [ Time Frame: 6 months ]


Information By: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncologí

Dates:
Date Received: February 23, 2013
Date Started: October 2011
Date Completion:
Last Updated: November 18, 2016
Last Verified: November 2016