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

NCT01799421 | Completed

• 1 other identifier: NEURISK
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 20

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%.

Conditions

Non-hematologic Cancer

Outcome Measures

Primary Outcomes (1)

• Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer

  6 months

Secondary Outcomes (4)

• 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

  6 months

• Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance

  6 months

Study Arms (1)

Non-haematologic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (20)

Hospital Teresa Herrera

A Coruña, A coruña, 15006, Spain

Location

Hospital Universitario Albacete

Albacete, Albacete, 02006, Spain

Location

Hospital Clínico Universitario San Juan de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Quirón

Barcelona, Barcelona, 08023, Spain

Location

Hospital de Basurto

Basurto, Bilbao, 48013, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Cáceres, 10003, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Dr. Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital de Donosti

San Sebastián, Guipuzcua, 20080, Spain

Location

Hospital de Lugo

Lugo, Lugo, 27004, Spain

Location

Hospital Morales Meseger

Murcia, Murcia, 30008, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Ourense, 32005, Spain

Location

Hospital Xeral

Vigo, Pontevedra, 36204, Spain

Location

Hospital de Santa Tecla

Tarragona, Tarragona, 43003, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, 45004, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Valladolid, 47005, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 26, 2013
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

ES (20)