Status:
COMPLETED
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
Lead Sponsor:
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Conditions:
Non-hematologic Cancer
Eligibility:
All Genders
18+ years
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 chemothera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01799421
Start Date
October 1 2011
End Date
December 1 2015
Last Update
November 21 2016
Active Locations (20)
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1
Hospital Teresa Herrera
A Coruña, A coruña, Spain, 15006
2
Hospital Universitario Albacete
Albacete, Albacete, Spain, 02006
3
Hospital Clínico Universitario San Juan de Alicante
Alicante, Alicante, Spain, 03010
4
Hospital Quirón
Barcelona, Barcelona, Spain, 08023