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Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study (VISTA)

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ClinicalTrials.gov Identifier: NCT02454530
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

Condition or disease Intervention/treatment
Chemotherapy-Induced Neutropenia Biological: Nivestim®

Detailed Description:

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

  • Baseline visit: prescription of Nivestim®.
  • Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
  • Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Study Type : Observational
Actual Enrollment : 1154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prophylactic Treatment For Chemo-induced Neutropenia. Use Of G-csf Biosimilar (Nivestim(Registered)) According To The Chemotherapy Context: Adjuvant Versus Metastatic.
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 18, 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cancer patients treated with Nivestim® Biological: Nivestim®



Primary Outcome Measures :
  1. Patterns of use of prophylactic Nivestim® for chemo-induced neutropenia [ Time Frame: End of the baseline visit (Patients are included at the time of the Nivestim® prescription prior to their chemotherapy) ]
    The patterns of use of Nivestim® will be described, globally and by subgroups (adjuvant and metastatic setting). It will be assessed from the profile of patients (infectious history, stage of the disease ...) and the oncologist motivations at initiation of prophylactic Nivestim® treatment


Secondary Outcome Measures :
  1. Tolerance to treatment with Nivestim® [ Time Frame: Each patient will be followed up to maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy ]
    The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation.

  2. Profile of patients under Nivestim® treatment [ Time Frame: End of baseline visit ]
    Patients' profiles treated with Nivestim® will be described from the questionnaire completed by the investigator during the baseline visit.

  3. Chemotherapy variations in terms of dose intensity and duration of cycles [ Time Frame: End of follow-up visit and final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]
    Chemotherapy variations (scheduled or unscheduled discontinuation; occurrence of neutropenia; occurrence of infection; any protocol amendment; prophylaxis with Nivestim®) will be described from the questionnaire completed by the investigator during the follow-up and final visits.

  4. Incidence of neutropenia and febrile neutropenia [ Time Frame: End of follow-up visit and final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]
    The incidence of neutropenia and febrile neutropenia will be described from the questionnaire completed by the investigator during the follow-up and final visits.

  5. Experience of patients treated with Nivestim® [ Time Frame: End of final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]
    Patients' experience treated with Nivestim® after the chemotherapy will be described from the questionnaire completed by the investigator during the final visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated
Criteria

Inclusion Criteria:

  • Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
  • Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
  • Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

  • Patients with contraindication of use of Nivestim®.
  • Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
  • Patients participating or having participated in the previous month in a clinical trial.
  • Patients refusing to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454530


  Show 92 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02454530     History of Changes
Other Study ID Numbers: VISTA
C1121007 ( Other Identifier: Alias Study Number )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases