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

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

Status: Completed

Conditions: Non-hematologic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01799421

NEURISK

Details and patient eligibility

About

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%.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 1 patient group

Non-haematologic cancer