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

Study Overview
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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%.

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

Conditions
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Non-hematologic Cancer

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-haematologic cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 |