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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-hematologic Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

NEURISK

NCT ID:

NCT01799421

Start Date:

October 2011

Completion Date:

July 2013

Related Keywords:

  • Non-hematologic Cancer
  • Neutropenia

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