Study Stopped
The study was stopped due to the judicial liquidation of the CRO in charge of this study.
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
VISTA
PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
2 other identifiers
observational
1,160
1 country
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
June 28, 2019
CompletedJune 28, 2019
March 1, 2019
2.1 years
May 22, 2015
November 9, 2018
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (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.
Inclusion visit (Week 1)
Secondary Outcomes (15)
Number of Participants Who Continued Chemotherapy
Follow-up visit (Week 3); End of study visit ( up to Week 19)
Number of Participants Who Discontinued Chemotherapy
Follow-up visit (Week 3); End of study visit ( up to Week 19)
Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit
Follow-up visit (Week 3)
Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia
Follow-up visit (Week 3)
Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia
Follow-up visit (Week 3)
- +10 more secondary outcomes
Other Outcomes (1)
Number of Participants in Different Profiles Receiving Treatment With Nivestim
End of study visit (up to Week 19)
Study Arms (1)
Cancer patients treated with Nivestim®
Interventions
Eligibility Criteria
Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (92)
Clinique Rambot La Provençale Tour d'Aygosi
Aix-en-Provence, 13100, France
Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie
Aix-en-Provence, 13616, France
ICO Centre Paul Papin Service d'Oncologie Médicale
Angers, 49000, France
CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie
Angers, 49933, France
CH d'Armentières Service Oncologie
Armentières, 59280, France
Centre Marie Curie A l'attention de Laëtitia
Arras, 62000, France
Centre Hospitalier Service Oncologie
Auxerre, 89011, France
Clinique du Dr Maymard Service d'Oncologie
Bastia, 20200, France
Hôpital de Falconaja Furiani Service d'Oncologie
Bastia, 20604, France
Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage
Beaune, 21200, France
CHU - Hôpital Jean Minjoz Service Oncologie Médicale
Besançon, 25030, France
Centre Hospitalier Service Onco-Hématologie
Béziers, 34525, France
Hôpital Avicenne Service Gastro-Entérologie
Bobigny, 93009, France
Clinique Tivoli
Bordeaux, BP 114 33030, France
Centre Hospitalier Service d'Oncologie
Boulogne-sur-Mer, 62321, France
CH de Fleyriat Service de Pneumologie
Bourg-en-Bresse, CS 90401 01012, France
CH de Fleyriat Service Onco-Hématologie
Bourg-en-Bresse, CS 90401 01012, France
Clinique Pasteur Lanroze Service Oncologie
Brest, 29200, France
Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie
Brest, 29609, France
Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie
Brest, 29609, France
Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines
Bron, 69677, France
Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique
Caen, 14076, France
Centre Hospitalier Service d'Oncologie
Carcassonne, 11010, France
Centre Hospitalier de Carcassonne Service d'Oncologie
Carcassonne, 11890, France
Medipole de Savoie Service Oncologie
Challes-les-Eaux, 73190, France
Médipole de Savoie
Challes-les-Eaux, 73190, France
CH William Morey Service d'Oncologie Médicale
Chalon-sur-Saône, 71321, France
CHP du Cotentin - Site de Cherbourg Service d'Oncologie
Cherbourg, 50100, France
Centre Hospitalier de Cholet Service d' Oncologie Médicale
Cholet, 49325, France
Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie
Cholet, 49325, France
Centre hospitalier Louis Pasteur Service de Pneumologie
Colmar, 68024, France
Hôpital Louis Pasteur Service de Pneumologie - Médecine F
Colmar, 68024, France
Centre de Radiothérapie GIE CROM
Compiègne, 60204, France
CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie
Dijon, BP 77908 21079, France
Centre Hospitalier de la Dracénie Service d'Oncologie
Draguignan, BP 249 83007, France
Centre Hospitalier de la Dracénie Service d'Oncologie
Draguignan, BP 249 83300, France
Centre Hospitalier Emile Durkheim Service Oncologie
Épinal, 88021, France
Clinique Chirurgicale Pasteur Service Oncologie Médicale
Évreux, 27025, France
CHI Fréjus Saint Raphaël Service d'Oncologie Médicale
Fréjus, 83608, France
CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie
Gap, 05007, France
Centre Hospitalier Service d'Oncologie
Gonesse, BP 30071 95503, France
Centre Hospitalier Service Onco-Hématologie
Le Mans, 72000, France
Centre de Radiothérapie Hartmann
Levallois-Perret, 92300, France
Institut Franco Britannique Service Oncologie Médicale
Levallois-Perret, 92300, France
Clinique Hartman Service de Radiothérapie
Levallois-Perret, 92309, France
Clinique Hartmann Service Oncologie
Levallois-Perret, 92309, France
Centre de Radiothérapie Hartmann
Levallois-Perret, CS 90004 92309, France
CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale
Lille, 59037, France
CHU Dupuytren Limoges Service d'Oncologie
Limoges, 87042, France
Centre Hospitalier Service de Médecine 2 - Hôpital de jour
Lons-le-Saunier, 39000, France
Centre Léon Bérard Service d'Oncologie Médicale
Lyon, 69008, France
Hôpital Privé Jean Mermoz Service d'Oncologie Médicale
Lyon, 69008, France
CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie
Lyon Cedez 07, 69365, France
Centre Hospitalier Privé Clairval Service de Cancérologie
Marseille, 13009, France
Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques
Marseille, 13915, France
Clinique Claude Bernard Service de Chimiothérapie
Metz, 57072, France
Clinique Claude Bernard Service Chimiothérapie
Metz, BP 45050 57072, France
Centre Hospitalier Layne Service d'Oncologie
Mont-de-Marsan, 40024, France
Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie
Montbéliard, 25200, France
Clinique Clementville Service d'Oncologie
Montpellier, 34000, France
CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie
Montpellier, 34295, France
Centre Hospitalier Emile Muller
Mulhouse, 68070, France
CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie
Mulhouse, 68070, France
Polyclinique de Gentilly Service Oncologie Médicale
Nancy, 54100, France
CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie
Nantes, 44093, France
CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale
Nantes, 44093, France
Centre Hospitalier de Narbonne Oncologie / Hématologie
Narbonne, 11108, France
Hôpital Américain
Neuilly-sur-Seine, 92200, France
Institut Mutualiste Montsouris Service Oncologie Médicale
Paris, 75014, France
Clinique Alleray Labrouste Service d'Oncologie Médicale
Paris, 75015, France
Hôpital Européen Georges Pompidou Service d'Oncologie Médicale
Paris, 75015, France
Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)
Paris, 75015, France
Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive
Paris, 75877, France
Hôpital Tenon Service d'oncologie médicale
Paris, 75970, France
Centre Hospitalier Service d'Oncologie
Perpignan, 66046, France
Centre Hospitalier Service de Pneumologie
Perpignan, BP 4052 66046, France
Centre Hospitalier Annecy Genevois Service Pneumologie
Pringy, 74370, France
Centre Hospitalier de la region d'Annecy Pole Medecine
Pringy, METZ TESSY 74374, France
CH de Cornouaille Service d'Oncologie Médicale
Quimper, 29107, France
Institut Jean Godinot
Reims, 51726, France
Clinique de l'Europe Unité d'Oncologie
Rouen, 76100, France
Hôpital de Saint-Avold Service Oncologie II
Saint-Avold, 57502, France
Clinique François 1er
Saint-Dizier, 52100, France
Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie
Saint-Grégoire, 35760, France
Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie
Saint-Grégoire, 35760, France
Centre Clinical Service d'Oncologie-Radiothérapie
Soyaux, 16800, France
Centre de Radiothérapie SCP Strasbourg Oncologie Libérale
Strasbourg, 67085, France
Hôpital Bel Air Service Pneumologie
Thionville, 57312, France
Hôpital de Thionville Service Oncologie Médicale
Thionville, BP 60327 57126, France
Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique
Toulouse, 31059, France
Clinique Pasteur
Toulouse, BP 27617 31076, France
Hôpital Bretonneau Service d'Oncologie Médicale
Tours, 37044, France
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2015
First Posted
May 27, 2015
Study Start
September 1, 2014
Primary Completion
October 18, 2016
Study Completion
January 1, 2017
Last Updated
June 28, 2019
Results First Posted
June 28, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share
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.