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

Non-hematologic Cancer Clinical Trial

— NEURISK  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799421
• Other study ID #: NEURISK
• Status: Completed
• Phase: N/A
• First received: February 23, 2013
• Last updated: November 18, 2016
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Neutropenia
• Non-hematologic Cancer

Locations

Country	Name	City	State
Spain	Hospital Teresa Herrera	A coruña
Spain	Hospital Universitario Albacete	Albacete
Spain	Hospital Clínico Universitario San Juan de Alicante	Alicante
Spain	Hospital Quirón	Barcelona
Spain	Hospital de Basurto	Basurto	Bilbao
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital de Lugo	Lugo
Spain	Hospital Morales Meseger	Murcia
Spain	Complejo Hospitalario de Ourense	Ourense
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital de Donosti	San Sebastián	Guipuzcua
Spain	Hospital de Santa Tecla	Tarragona
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital Xeral	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer		6 months	No
Secondary	Occurrence of serious adverse events		6 months	Yes
Secondary	Analyze costs to treat febrile neutropenia and neutropenia grade 3/4		6 months	No
Secondary	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	Yes
Secondary	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	No