Clinical trial · Observational
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.
NCT01799421CI-TRIAL-00024856NEURISKcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-hematologic Cancer | Non-Hematologic Malignancy | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Non-haematologic cancer
Primary outcomes (1)
- measure
- Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- Occurrence of serious adverse events
- timeFrame
- 6 months
- measure
- Analyze costs to treat febrile neutropenia and neutropenia grade 3/4
- timeFrame
- 6 months
- measure
- Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.