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Chemotherapy-Induced NeutropeniaVISTANCT02454530

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

An observational study of Chemotherapy-Induced Neutropenia, run by Pfizer at 92 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-Induced Neutropenia
What is being tested?
Nivestim®
How many people
1,160 participants
Where
92 sitesFrance
Study dates
Sep 2014to Jan 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

France92 sites

  • Clinique Rambot La Provençale Tour d'Aygosi

    Aix-en-Provence, 13100

  • Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie

    Aix-en-Provence, 13616

  • ICO Centre Paul Papin Service d'Oncologie Médicale

    Angers, 49000

  • CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie

    Angers, 49933

  • CH d'Armentières Service Oncologie

    Armentières, 59280

  • Centre Marie Curie A l'attention de Laëtitia

    Arras, 62000

  • Centre Hospitalier Service Oncologie

    Auxerre, 89011

  • Clinique du Dr Maymard Service d'Oncologie

    Bastia, 20200

  • Hôpital de Falconaja Furiani Service d'Oncologie

    Bastia, 20604

  • Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage

    Beaune, 21200

  • CHU - Hôpital Jean Minjoz Service Oncologie Médicale

    Besançon, 25030

  • Centre Hospitalier Service Onco-Hématologie

    Béziers, 34525

  • Hôpital Avicenne Service Gastro-Entérologie

    Bobigny, 93009

  • Clinique Tivoli

    Bordeaux, BP 114 33030

  • Centre Hospitalier Service d'Oncologie

    Boulogne-sur-Mer, 62321

  • CH de Fleyriat Service de Pneumologie

    Bourg-en-Bresse, CS 90401 01012

  • CH de Fleyriat Service Onco-Hématologie

    Bourg-en-Bresse, CS 90401 01012

  • Clinique Pasteur Lanroze Service Oncologie

    Brest, 29200

  • Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie

    Brest, 29609

  • Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie

    Brest, 29609

  • Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines

    Bron, 69677

  • Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique

    Caen, 14076

  • Centre Hospitalier Service d'Oncologie

    Carcassonne, 11010

  • Centre Hospitalier de Carcassonne Service d'Oncologie

    Carcassonne, 11890

  • Medipole de Savoie Service Oncologie

    Challes-les-Eaux, 73190

  • Médipole de Savoie

    Challes-les-Eaux, 73190

  • CH William Morey Service d'Oncologie Médicale

    Chalon-sur-Saône, 71321

  • CHP du Cotentin - Site de Cherbourg Service d'Oncologie

    Cherbourg, 50100

  • Centre Hospitalier de Cholet Service d' Oncologie Médicale

    Cholet, 49325

  • Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie

    Cholet, 49325

  • Centre hospitalier Louis Pasteur Service de Pneumologie

    Colmar, 68024

  • Hôpital Louis Pasteur Service de Pneumologie - Médecine F

    Colmar, 68024

  • Centre de Radiothérapie GIE CROM

    Compiègne, 60204

  • CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie

    Dijon, BP 77908 21079

  • Centre Hospitalier de la Dracénie Service d'Oncologie

    Draguignan, BP 249 83007

  • Centre Hospitalier de la Dracénie Service d'Oncologie

    Draguignan, BP 249 83300

  • Centre Hospitalier Emile Durkheim Service Oncologie

    Épinal, 88021

  • Clinique Chirurgicale Pasteur Service Oncologie Médicale

    Évreux, 27025

  • CHI Fréjus Saint Raphaël Service d'Oncologie Médicale

    Fréjus, 83608

  • CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie

    Gap, 05007

  • Centre Hospitalier Service d'Oncologie

    Gonesse, BP 30071 95503

  • Centre Hospitalier Service Onco-Hématologie

    Le Mans, 72000

  • Centre de Radiothérapie Hartmann

    Levallois-Perret, 92300

  • Institut Franco Britannique Service Oncologie Médicale

    Levallois-Perret, 92300

  • Clinique Hartman Service de Radiothérapie

    Levallois-Perret, 92309

  • Clinique Hartmann Service Oncologie

    Levallois-Perret, 92309

  • Centre de Radiothérapie Hartmann

    Levallois-Perret, CS 90004 92309

  • CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale

    Lille, 59037

  • CHU Dupuytren Limoges Service d'Oncologie

    Limoges, 87042

  • Centre Hospitalier Service de Médecine 2 - Hôpital de jour

    Lons-le-Saunier, 39000

  • Centre Léon Bérard Service d'Oncologie Médicale

    Lyon, 69008

  • Hôpital Privé Jean Mermoz Service d'Oncologie Médicale

    Lyon, 69008

  • CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie

    Lyon Cedez 07, 69365

  • Centre Hospitalier Privé Clairval Service de Cancérologie

    Marseille, 13009

  • Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques

    Marseille, 13915

  • Clinique Claude Bernard Service de Chimiothérapie

    Metz, 57072

  • Clinique Claude Bernard Service Chimiothérapie

    Metz, BP 45050 57072

  • Centre Hospitalier Layne Service d'Oncologie

    Mont-de-Marsan, 40024

  • Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie

    Montbéliard, 25200

  • Clinique Clementville Service d'Oncologie

    Montpellier, 34000

  • CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie

    Montpellier, 34295

  • Centre Hospitalier Emile Muller

    Mulhouse, 68070

  • CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie

    Mulhouse, 68070

  • Polyclinique de Gentilly Service Oncologie Médicale

    Nancy, 54100

  • CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie

    Nantes, 44093

  • CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale

    Nantes, 44093

  • Centre Hospitalier de Narbonne Oncologie / Hématologie

    Narbonne, 11108

  • Hôpital Américain

    Neuilly-sur-Seine, 92200

  • Institut Mutualiste Montsouris Service Oncologie Médicale

    Paris, 75014

  • Clinique Alleray Labrouste Service d'Oncologie Médicale

    Paris, 75015

  • Hôpital Européen Georges Pompidou Service d'Oncologie Médicale

    Paris, 75015

  • Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)

    Paris, 75015

  • Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive

    Paris, 75877

  • Hôpital Tenon Service d'oncologie médicale

    Paris, 75970

  • Centre Hospitalier Service d'Oncologie

    Perpignan, 66046

  • Centre Hospitalier Service de Pneumologie

    Perpignan, BP 4052 66046

  • Centre Hospitalier Annecy Genevois Service Pneumologie

    Pringy, 74370

  • Centre Hospitalier de la region d'Annecy Pole Medecine

    Pringy, METZ TESSY 74374

  • CH de Cornouaille Service d'Oncologie Médicale

    Quimper, 29107

  • Institut Jean Godinot

    Reims, 51726

  • Clinique de l'Europe Unité d'Oncologie

    Rouen, 76100

  • Hôpital de Saint-Avold Service Oncologie II

    Saint-Avold, 57502

  • Clinique François 1er

    Saint-Dizier, 52100

  • Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie

    Saint-Grégoire, 35760

  • Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie

    Saint-Grégoire, 35760

  • Centre Clinical Service d'Oncologie-Radiothérapie

    Soyaux, 16800

  • Centre de Radiothérapie SCP Strasbourg Oncologie Libérale

    Strasbourg, 67085

  • Hôpital Bel Air Service Pneumologie

    Thionville, 57312

  • Hôpital de Thionville Service Oncologie Médicale

    Thionville, BP 60327 57126

  • Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, BP 27617 31076

  • Hôpital Bretonneau Service d'Oncologie Médicale

    Tours, 37044

Other trials in France

About this study

Official title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.

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.

Read the 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.
Being tested
Nivestim®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivestim®Biological

Study groups in NCT02454530
Study groupRoleWhat they receive
Cancer patients treated with Nivestim®Not described
Receives: Biological: Nivestim®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim

    The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable.

    Measured: Inclusion visit (Week 1)

Secondary outcomes (15)

  1. Number of Participants Who Continued Chemotherapy

    Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as a part of a standardize treatment regimen. Chemotherapy may be given with curative intent, or it may aim to prolong life or to reduce symptoms.

    Measured: Follow-up visit (Week 3); End of study visit ( up to Week 19)

  2. Number of Participants Who Discontinued Chemotherapy

    Measured: Follow-up visit (Week 3); End of study visit ( up to Week 19)

  3. Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit

    Measured: Follow-up visit (Week 3)

  4. Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia

    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.

    Measured: Follow-up visit (Week 3)

  5. Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia

    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.

    Measured: Follow-up visit (Week 3)

  6. Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit

    The reasons for unplanned discontinuation of chemotherapy included neutropenia, febrile neutropenia, other toxicity, development of resistance to treatment and other. Also, one participant could have more than one reason for unplanned discontinuation.

    Measured: End of study visit (up to Week 19)

  7. Number of Participants With Change in Chemotherapy Protocol at End of Study Visit

    Number of participants with change in chemotherapy protocol due to each conditions (neutropenia, febrile neutropenia, neutropenia/febrile neutropenia, other toxicity, neutropenia/other toxicity) has been reported in this outcome measure.

    Measured: End of study visit (up to Week 19)

  8. Number of Participants With Neutropenia and Febrile Neutropenia

    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microL in blood) and was classified as Grade 1 (mild) with an ANC of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. The incidence of neutropenia (between follow up and final visit) were described from the questionnaire completed by the investigator during the final visit. Febrile neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 degree celsius for >1 hour and ANC less than (<) 1.0 *10^9 neutrophils per liter. The incidence of febrile neutropenia were described from the questionnaire completed by the investigator during the follow-up and final visits. Only those categories which had atleast 1 abnormality have been reported in this outcome measure.

    Measured: Follow-up visit (Week 3); End of study visit (up to Week 19)

  9. Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study

    Change in the disease status of the participant was measured by the change in the count of neutrophils (NPs), platelets and leukocytes as reported in this outcome measure.

    Measured: Inclusion visit (Week 1), End of study visit (up to Week 19)

  10. Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study

    The Karnofsky performance scale was used for rating participant activities of daily living. The KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. The lower the Karnofsky score, the worse the survival for most serious illnesses. The score ranges included as 100 (Normal; no complaints), 90 (Able to carry on normal activity), 80 (Normal activity with effort), 70 (Cares for self; unable to carry on normal activity), 60 (Requires occasional assistance, but is able to care), 50 (Requires considerable assistance and frequent medical care), 40 (Disabled; requires special care), 30 (Severely disabled), 20 (Very sick; hospital admission necessary), 10 (Moribund; fatal processes progressing rapidly) and 0 (Dead).

    Measured: Inclusion visit (Week 1); End of study visit (up to Week 19)

  11. Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit

    Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure.

    Measured: Inclusion visit (Week 1), End of study visit (up to Week 19)

  12. Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site

    Pain experienced by participant at the injection site was measured on a scale 0 to 10 (0 = no pain to 10 = maximum pain), where higher score indicates maximum pain.

    Measured: End of study visit (up to Week 19)

  13. Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment

    Participant's satisfaction after the chemotherapy treatment was assessed by the doctor and was categorized under the 4 categories as very satisfied, satisfied, not very satisfied and dissatisfied.

    Measured: End of study visit (up to Week 19)

  14. Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary

    Measured: End of study visit (up to Week 19)

  15. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after Inclusion visit up to end of study visit (up to Week 19). AEs included both serious and non-serious adverse event. If a participant who reported an SAE also reported an AE that was not serious, that would count as 1 participant in the total number of participants reporting AEs.

    Measured: Inclusion visit (Week 1) up to end of study visit (up to Week 19)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2015 (estimated)
  2. Study startSep 2014
  3. Primary completion18 Oct 2016
  4. Study completionJan 2017

Why it stopped: The study was stopped due to the judicial liquidation of the CRO in charge of this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454530
Sponsor's protocol ID
VISTA
Other IDs
C1121007
Acronym
VISTA
Status last verified
Mar 2019
First submitted
22 May 2015
Last updated
28 Jun 2019
Data monitoring committee
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-Induced Neutropenia, run by Pfizer at 92 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim (time frame: Inclusion visit (Week 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02454530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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