Clinical trial NCT01799421: Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-hematologic Cancer
Lead sponsor: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-hematologic cancer that will start chemotherapy treatment.

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%.


Eligibility 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.

Primary outcomes:
measure: Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of serious adverse events
timeFrame: 6 months
measure: Analyze costs to treat febrile neutropenia and neutropenia grade 3/4
timeFrame: 6 months
measure: Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment
timeFrame: 6 months
measure: Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Bilbao
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: San Sebastián
country: Spain
facility: Hospital de Donosti
state: Guipuzcua
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Xeral
state: Pontevedra
city: A coruña
country: Spain
facility: Hospital Teresa Herrera
city: Albacete
country: Spain
facility: Hospital Universitario Albacete
city: Alicante
country: Spain
facility: Hospital Clínico Universitario San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital Quirón
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Lugo
country: Spain
facility: Hospital de Lugo
city: Murcia
country: Spain
facility: Hospital Morales Meseger
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Tarragona
country: Spain
facility: Hospital de Santa Tecla
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
Study officials:
References: