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

NCT ID: NCT01799421

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

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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%.

Detailed Description

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Conditions

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Non-hematologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-haematologic cancer

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Teresa Herrera

A Coruña, A coruña, Spain

Site Status

Hospital Universitario Albacete

Albacete, Albacete, Spain

Site Status

Hospital Clínico Universitario San Juan de Alicante

Alicante, Alicante, Spain

Site Status

Hospital Quirón

Barcelona, Barcelona, Spain

Site Status

Hospital de Basurto

Basurto, Bilbao, Spain

Site Status

Hospital San Pedro de Alcántara

Cáceres, Cáceres, Spain

Site Status

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Site Status

Hospital Dr. Josep Trueta

Girona, Girona, Spain

Site Status

Hospital Virgen de las Nieves

Granada, Granada, Spain

Site Status

Hospital de Donosti

San Sebastián, Guipuzcua, Spain

Site Status

Hospital de Lugo

Lugo, Lugo, Spain

Site Status

Hospital Morales Meseger

Murcia, Murcia, Spain

Site Status

Hospital de Navarra

Pamplona, Navarre, Spain

Site Status

Complejo Hospitalario de Ourense

Ourense, Ourense, Spain

Site Status

Hospital Xeral

Vigo, Pontevedra, Spain

Site Status

Hospital de Santa Tecla

Tarragona, Tarragona, Spain

Site Status

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Site Status

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Site Status

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain

Site Status

Hospital Clínico de Valladolid

Valladolid, Valladolid, Spain

Site Status

Countries

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Spain

Other Identifiers

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NEURISK

Identifier Type: -

Identifier Source: org_study_id