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

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ClinicalTrials.gov Identifier: NCT01799421
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología

Tracking Information
First Submitted Date February 23, 2013
First Posted Date February 26, 2013
Last Update Posted Date November 21, 2016
Study Start Date October 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2013)
Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2013)
  • Occurrence of serious adverse events [ Time Frame: 6 months ]
  • Analyze costs to treat febrile neutropenia and neutropenia grade 3/4 [ Time Frame: 6 months ]
  • Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment [ Time Frame: 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.
  • Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: February 25, 2013)
  • Occurrence of serious adverse events [ Time Frame: 6 months ]
  • Analyze costs to treat febrile neutropenia and neutropenia grade 3/4 [ Time Frame: 6 months ]
  • Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment [ Time Frame: 6 months ]
  • Study the occurrence of febrile neutropenia and neutropenia grade 3/4 vs fulfillment of chemotherapy treatment [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
Official Title Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with non-hematologic cancer that will start chemotherapy treatment.
Condition Non-hematologic Cancer
Intervention Not Provided
Study Groups/Cohorts Non-haematologic cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2016)
420
Original Estimated Enrollment
 (submitted: February 25, 2013)
440
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01799421
Other Study ID Numbers NEURISK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Study Sponsor Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Collaborators Not Provided
Investigators Not Provided
PRS Account Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
Verification Date November 2016