Clinical trial NCT02454530: Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Official title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chemotherapy-Induced Neutropenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2015-05-27
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim
timeFrame: Inclusion visit (Week 1)
Secondary outcomes:
measure: Number of Participants Who Continued Chemotherapy
timeFrame: Follow-up visit (Week 3); End of study visit ( up to Week 19)
measure: Number of Participants Who Discontinued Chemotherapy
timeFrame: Follow-up visit (Week 3); End of study visit ( up to Week 19)
measure: Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit
timeFrame: Follow-up visit (Week 3)
measure: Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia
timeFrame: Follow-up visit (Week 3)
measure: Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia
timeFrame: Follow-up visit (Week 3)
measure: Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit
timeFrame: End of study visit (up to Week 19)
measure: Number of Participants With Change in Chemotherapy Protocol at End of Study Visit
timeFrame: End of study visit (up to Week 19)
measure: Number of Participants With Neutropenia and Febrile Neutropenia
timeFrame: Follow-up visit (Week 3); End of study visit (up to Week 19)
measure: Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study
timeFrame: Inclusion visit (Week 1), End of study visit (up to Week 19)
measure: Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study
timeFrame: Inclusion visit (Week 1); End of study visit (up to Week 19)
measure: Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit
timeFrame: Inclusion visit (Week 1), End of study visit (up to Week 19)
measure: Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site
timeFrame: End of study visit (up to Week 19)
measure: Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment
timeFrame: End of study visit (up to Week 19)
measure: Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary
timeFrame: End of study visit (up to Week 19)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Inclusion visit (Week 1) up to end of study visit (up to Week 19)
Other outcomes:
measure: Number of Participants in Different Profiles Receiving Treatment With Nivestim
timeFrame: End of study visit (up to Week 19)
Locations:
city: Aix En Provence
country: France
facility: Clinique Rambot La Provençale Tour d'Aygosi
city: Aix En Provence
country: France
facility: Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie
city: Angers Cedex 9
country: France
facility: CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie
city: Angers
country: France
facility: ICO Centre Paul Papin Service d'Oncologie Médicale
city: Armentieres
country: France
facility: CH d'Armentières Service Oncologie
city: Arras Cedex
country: France
facility: Centre Marie Curie A l'attention de Laëtitia
city: Auxerre Cedex
country: France
facility: Centre Hospitalier Service Oncologie
city: Bastia Cedex
country: France
facility: Hôpital de Falconaja Furiani Service d'Oncologie
city: Bastia
country: France
facility: Clinique du Dr Maymard Service d'Oncologie
city: Beaune
country: France
facility: Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage
city: Besancon Cedex
country: France
facility: CHU - Hôpital Jean Minjoz Service Oncologie Médicale
city: Beziers Cedex
country: France
facility: Centre Hospitalier Service Onco-Hématologie
city: Bobigny Cedex
country: France
facility: Hôpital Avicenne Service Gastro-Entérologie
city: Bordeaux Cedex
country: France
facility: Clinique Tivoli
city: Boulogne Sur Mer Cedex
country: France
facility: Centre Hospitalier Service d'Oncologie
city: Bourg En Bresse
country: France
facility: CH de Fleyriat Service de Pneumologie
city: Bourg En Bresse
country: France
facility: CH de Fleyriat Service Onco-Hématologie
city: Brest Cedex 2
country: France
facility: Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie
city: Brest Cedex
country: France
facility: Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie
city: Brest
country: France
facility: Clinique Pasteur Lanroze Service Oncologie
city: Bron Cedex
country: France
facility: Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines
city: Caen Cedex 5
country: France
facility: Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique
city: Carcassonne Cedex 9
country: France
facility: Centre Hospitalier de Carcassonne Service d'Oncologie
city: Carcassonne Cedex
country: France
facility: Centre Hospitalier Service d'Oncologie
city: Challes Les Eaux
country: France
facility: Medipole de Savoie Service Oncologie
city: Challes Les Eaux
country: France
facility: Médipole de Savoie
city: Chalon Sur Saone Cedex
country: France
facility: CH William Morey Service d'Oncologie Médicale
city: Cherbourg
country: France
facility: CHP du Cotentin - Site de Cherbourg Service d'Oncologie
city: Cholet Cedex
country: France
facility: Centre Hospitalier de Cholet Service d' Oncologie Médicale
city: Cholet
country: France
facility: Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie
city: Colmar Cedex
country: France
facility: Centre hospitalier Louis Pasteur Service de Pneumologie
city: Colmar Cedex
country: France
facility: Hôpital Louis Pasteur Service de Pneumologie - Médecine F
city: Compiegne
country: France
facility: Centre de Radiothérapie GIE CROM
city: Dijon Cedex
country: France
facility: CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie Service d'Oncologie
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie Service d'Oncologie
city: Epinal Cedex
country: France
facility: Centre Hospitalier Emile Durkheim Service Oncologie
city: Evreux Cedex
country: France
facility: Clinique Chirurgicale Pasteur Service Oncologie Médicale
city: Frejus
country: France
facility: CHI Fréjus Saint Raphaël Service d'Oncologie Médicale
city: GAP
country: France
facility: CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie
city: Gonesse Cedex
country: France
facility: Centre Hospitalier Service d'Oncologie
city: Le Mans
country: France
facility: Centre Hospitalier Service Onco-Hématologie
city: Levallois Perret Cedex
country: France
facility: Clinique Hartman Service de Radiothérapie
city: Levallois Perret Cedex
country: France
facility: Clinique Hartmann Service Oncologie
city: Levallois Perret Cedex
country: France
facility: Centre de Radiothérapie Hartmann
city: Levallois Perret
country: France
facility: Centre de Radiothérapie Hartmann
city: Levallois Perret
country: France
facility: Institut Franco Britannique Service Oncologie Médicale
city: Lille Cedex
country: France
facility: CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale
city: Limoges
country: France
facility: CHU Dupuytren Limoges Service d'Oncologie
city: Lons le Saunier Cedex
country: France
facility: Centre Hospitalier Service de Médecine 2 - Hôpital de jour
city: Lyon Cedez 07
country: France
facility: CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie
city: Lyon
country: France
facility: Centre Léon Bérard Service d'Oncologie Médicale
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz Service d'Oncologie Médicale
city: Marseille Cedex 20
country: France
facility: Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques
city: Marseille
country: France
facility: Centre Hospitalier Privé Clairval Service de Cancérologie
city: Metz Cedex 03
country: France
facility: Clinique Claude Bernard Service de Chimiothérapie
city: Metz Cedex 03
country: France
facility: Clinique Claude Bernard Service Chimiothérapie
city: Mont de Marsan Cedex
country: France
facility: Centre Hospitalier Layne Service d'Oncologie
city: Montbeliard
country: France
facility: Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie
city: Montpellier
country: France
facility: Clinique Clementville Service d'Oncologie
city: Mulhouse Cedex
country: France
facility: Centre Hospitalier Emile Muller
city: Mulhouse Cedex
country: France
facility: CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie
city: Nancy
country: France
facility: Polyclinique de Gentilly Service Oncologie Médicale
city: Nantes Cedex 1
country: France
facility: CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale
city: Narbonne
country: France
facility: Centre Hospitalier de Narbonne Oncologie / Hématologie
city: Neuilly Sur Seine
country: France
facility: Hôpital Américain
city: Paris Cedex 18
country: France
facility: Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive
city: Paris Cedex 20
country: France
facility: Hôpital Tenon Service d'oncologie médicale
city: Paris
country: France
facility: Institut Mutualiste Montsouris Service Oncologie Médicale
city: Paris
country: France
facility: Clinique Alleray Labrouste Service d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou Service d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)
city: Perpignan
country: France
facility: Centre Hospitalier Service d'Oncologie
city: Perpignan
country: France
facility: Centre Hospitalier Service de Pneumologie
city: Pringy Cedex
country: France
facility: Centre Hospitalier Annecy Genevois Service Pneumologie
city: Pringy Cedex
country: France
facility: Centre Hospitalier de la region d'Annecy Pole Medecine
city: Quimper Cedex
country: France
facility: CH de Cornouaille Service d'Oncologie Médicale
city: Reims Cedex
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Clinique de l'Europe Unité d'Oncologie
city: Saint Avold Cedex
country: France
facility: Hôpital de Saint-Avold Service Oncologie II
city: Saint Gregoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie
city: Saint Gregoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie
city: Saint-dizier
country: France
facility: Clinique François 1er
city: Soyaux
country: France
facility: Centre Clinical Service d'Oncologie-Radiothérapie
city: Strasbourg Cedex
country: France
facility: Centre de Radiothérapie SCP Strasbourg Oncologie Libérale
city: Thionville Cedex
country: France
facility: Hôpital de Thionville Service Oncologie Médicale
city: Thionville
country: France
facility: Hôpital Bel Air Service Pneumologie
city: Toulouse Cedex 3
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique
city: Tours Cedex 9
country: France
facility: Hôpital Bretonneau Service d'Oncologie Médicale
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: