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

Predictive Models of 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%.

Study Overview

• Status: Completed
• Conditions: Non-hematologic Cancer

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• Spain
  • A coruña, Spain, 15006
    • Hospital Teresa Herrera
  • Albacete, Spain, 02006
    • Hospital Universitario Albacete
  • Alicante, Spain, 03010
    • Hospital Clínico Universitario San Juan de Alicante
  • Barcelona, Spain, 08023
    • Hospital Quirón
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Girona, Spain, 17007
    • Hospital Dr. Josep Trueta
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves
  • Lugo, Spain, 27004
    • Hospital de Lugo
  • Murcia, Spain, 30008
    • Hospital Morales Meseger
  • Ourense, Spain, 32005
    • Complejo Hospitalario de Ourense
  • Tarragona, Spain, 43003
    • Hospital de Santa Tecla
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Valladolid, Spain, 47005
    • Hospital Clínico de Valladolid
  • Bilbao
    • Basurto, Bilbao, Spain, 48013
      • Hospital de Basurto
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital de Jerez
  • Guipuzcua
    • San Sebastián, Guipuzcua, Spain, 20080
      • Hospital de Donosti
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-hematologic cancer that will start chemotherapy treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Non-haematologic cancer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of serious adverse events		6 months
Analyze costs to treat febrile neutropenia and neutropenia grade 3/4		6 months
Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment	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.	6 months
Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance	The impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance (yes/no) will be evaluated using a chi-square test.	6 months

Collaborators and Investigators

• Sponsor: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 23, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: NEURISK