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Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy (NEURISK)

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ClinicalTrials.gov Identifier: NCT01799421
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología

Study Description
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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%.

Condition or disease
Non-hematologic Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

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MedlinePlus related topics: Fever

Groups and Cohorts
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Group/Cohort
Non-haematologic cancer


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

Secondary Outcome Measures :
  1. Occurrence of serious adverse events [ Time Frame: 6 months ]
  2. Analyze costs to treat febrile neutropenia and neutropenia grade 3/4 [ Time Frame: 6 months ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-hematologic cancer that will start chemotherapy treatment.
Criteria

Inclusion Criteria:

  • Male or female > 18 years
  • Histologically confirmed solid tumor.
  • Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
  • Subject to initiate a chemotherapy (ie, cycle 1, day 1)
  • The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
  • Planning a minimum of 3 cycles chemotherapy.
  • Adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm3.
  • Adequate hepatic and renal function, defined by: bilirubin <1.5 times the normal value, ALT and AST <3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine <1.5 times upper normal value
  • ECOG ≤ 2.
  • Informed consent

Exclusion Criteria:

  • Patients under treatment with an investigational treatment.
  • Active infection in the last 72 h before starting chemotherapy.
  • Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia <10% or >20%.
  • Patients with concomitant chemoradiotherapy.
  • Patients being treated with biological drugs in monotherapy.
  • Any other condition causing neutropenia.
  • History of bone marrow transplant or stem cells.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799421


Locations
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Sponsors and Collaborators
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
More Information
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Responsible Party: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
ClinicalTrials.gov Identifier: NCT01799421    
Other Study ID Numbers: NEURISK
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Agranulocytosis
 Leukopenia
Leukocyte Disorders
Hematologic Diseases