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

Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología20 sites in 1 country420 target enrollmentOctober 2011

ConditionsNon-hematologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-hematologic Cancer
Sponsor: Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Enrollment: 420
Locations: 20
Primary Endpoint: Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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%.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

December 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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 / mm
•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
•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.

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Secondary Outcomes

Analyze costs to treat febrile neutropenia and neutropenia grade 3/4(6 months)
Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance(6 months)
Occurrence of serious adverse events(6 months)
Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment(6 months)