Non-hematologic Cancer
Conditions
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%.
Interventions
None listed
Sponsors
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance | 6 months | The impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance (yes/no) will be evaluated using a chi-square test. |
Countries
Spain
Outcome results
None listed