Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
- Conditions
- Non-hematologic Cancer
- Registration Number
- NCT01799421
- Lead Sponsor
- Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 The impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance (yes/no) will be evaluated using a chi-square test.
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 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.
Trial Locations
- Locations (20)
Hospital de Basurto
🇪🇸Basurto, Bilbao, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital de Donosti
🇪🇸San Sebastián, Guipuzcua, Spain
Hospital Teresa Herrera
🇪🇸A coruña, Spain
Hospital Universitario Albacete
🇪🇸Albacete, Spain
Hospital Clínico Universitario San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Quirón
🇪🇸Barcelona, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital de Lugo
🇪🇸Lugo, Spain
Hospital Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Morales Meseger
🇪🇸Murcia, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital de Santa Tecla
🇪🇸Tarragona, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Complejo Hospitalario de Ourense
🇪🇸Ourense, Spain
Hospital Xeral
🇪🇸Vigo, Pontevedra, Spain