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Completed

NCT Number: NCT01799421

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

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%.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Teresa Herrera, A Coruña, A coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología

Other

Registry information

Official study title

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

Acronym: NEURISK

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 26, 2013
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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