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Spots Global Cancer Trial Database for Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

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Trial Identification

Brief Title: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

Official Title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

Study ID: NCT01459653

Interventions

Study Description

Brief Summary: This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sandoz Investigational Site, Innsbruck, , Austria

Sandoz Investigational Site, Kufstein, , Austria

Sandoz Investigational Site, Leoben, , Austria

Sandoz Investigational Site, Deurne, , Belgium

Sandoz Investigational Site, Tournai, , Belgium

Sandoz Investigational Site, Cheb, , Czech Republic

Sandoz Investigational Site, Chomutov, , Czech Republic

Sandoz Investigational Site, Praha, , Czech Republic

Sandoz Investigational Site, Teplice, , Czech Republic

Sandoz Investigational Site, Vítkovice, , Czech Republic

Sandoz Investigational Site, Agen, , France

Sandoz Investigational Site, Arras, , France

Sandoz Investigational Site, Avignon, , France

Sandoz Investigational Site, Bayonne, , France

Sandoz Investigational Site, Beauvais Cedex, , France

Sandoz Investigational Site, Blois, , France

Sandoz Investigational Site, Bois Guillaume Cedex, , France

Sandoz Investigational Site, Bordeaux Cedex, , France

Sandoz Investigational Site, Bordeaux, , France

Sandoz Investigational Site, Boulogne Sur Mer cedex, , France

Sandoz Investigational Site, Brest Cedex 2, , France

Sandoz Investigational Site, Colmar CEDEX, , France

Sandoz Investigational Site, Compiègne, , France

Sandoz Investigational Site, Gap Cedex, , France

Sandoz Investigational Site, Grenoble, , France

Sandoz Investigational Site, Libourne, , France

Sandoz Investigational Site, Lille Cedex, , France

Sandoz Investigational Site, Lyon 8, , France

Sandoz Investigational Site, Lyon Cedex 03, , France

Sandoz Investigational Site, Marseille, , France

Sandoz Investigational Site, Melun, , France

Sandoz Investigational Site, Montauban Cedex, , France

Sandoz Investigational Site, Montpellier Cedex 5, , France

Sandoz Investigational Site, Nancy, , France

Sandoz Investigational Site, Nîmes Cedex 9, , France

Sandoz Investigational Site, Orléans, , France

Sandoz Investigational Site, Paris Cedex 12, , France

Sandoz Investigational Site, Paris Cedex 15, , France

Sandoz Investigational Site, Perpignan, , France

Sandoz Investigational Site, Pierre Bénite, , France

Sandoz Investigational Site, Poitiers, , France

Sandoz Investigational Site, Reims Cedex, , France

Sandoz Investigational Site, Sainte-Foy-lès-Lyon, , France

Sandoz Investigational Site, Strasbourg Cedex, , France

Sandoz Investigational Site, Berlin, , Germany

Sandoz Investigational Site, Chemnitz, , Germany

Sandoz Investigational Site, Coburg, , Germany

Sandoz Investigational Site, Dortmund, , Germany

Sandoz Investigational Site, Erlangen, , Germany

Sandoz Investigational Site, Frankfurt, , Germany

Sandoz Investigational Site, Gera, , Germany

Sandoz Investigational Site, Hamburg, , Germany

Sandoz Investigational Site, Heinsberg, , Germany

Sandoz Investigational Site, Herne, , Germany

Sandoz Investigational Site, Langen, , Germany

Sandoz Investigational Site, Lehrte, , Germany

Sandoz Investigational Site, Leipzig, , Germany

Sandoz Investigational Site, Lübeck, , Germany

Sandoz Investigational Site, Munich, , Germany

Sandoz Investigational Site, Mülheim a. d. Ruhr, , Germany

Sandoz Investigational Site, Weiden, , Germany

Sandoz Investigational Site, Wismar, , Germany

Sandoz Investigational Site, Witten, , Germany

Sandoz Investigational Site, Wolfsburg, , Germany

Sandoz Investigational Site, Würselen, , Germany

Sandoz Investigational Site, Budapest, , Hungary

Sandoz Investigational Site, Gyor, , Hungary

Sandoz Investigational Site, Kecskemet, , Hungary

Sandoz Investigational Site, Pecs, , Hungary

Sandoz Investigational Site, Szekszard, , Hungary

Sandoz Investigational Site, Szombathely, , Hungary

Sandoz Investigational Site, Avezzano, , Italy

Sandoz Investigational Site, Avola, , Italy

Sandoz Investigational Site, Bari, , Italy

Sandoz Investigational Site, Campobasso, , Italy

Sandoz Investigational Site, Colleferro, , Italy

Sandoz Investigational Site, Cosenza, , Italy

Sandoz Investigational Site, Cuneo, , Italy

Sandoz Investigational Site, Frosinone, , Italy

Sandoz Investigational Site, Gaeta, , Italy

Sandoz Investigational Site, Genova, , Italy

Sandoz Investigational Site, La Spezia, , Italy

Sandoz Investigational Site, Matera, , Italy

Sandoz Investigational Site, Milano, , Italy

Sandoz Investigational Site, Monza, , Italy

Sandoz Investigational Site, Rieti, , Italy

Sandoz Investigational Site, Roma, , Italy

Sandoz Investigational Site, S. Giovanni Rotondo, , Italy

Sandoz Investigational Site, Sora, , Italy

Sandoz Investigational Site, Torino, , Italy

Sandoz Investigational Site, Białystok, , Poland

Sandoz Investigational Site, Brzozów, , Poland

Sandoz Investigational Site, Bydgoszcz, , Poland

Sandoz Investigational Site, Gdańsk, , Poland

Sandoz Investigational Site, Krakow, , Poland

Sandoz Investigational Site, Kraków, , Poland

Sandoz Investigational Site, Lublin, , Poland

Sandoz Investigational Site, Przemyśl, , Poland

Sandoz Investigational Site, Warszawa, , Poland

Sandoz Investigational Site, Wodzislaw Slaski, , Poland

Sandoz Investigational Site, Bucuresti, , Romania

Sandoz Investigational Site, Suceava, , Romania

Sandoz Investigational Site, Timisoara, , Romania

Sandoz Investigational Site, Tirgu Mures, , Romania

Sandoz Investigational Site, Alicante, , Spain

Sandoz Investigational Site, Barcelona, , Spain

Sandoz Investigational Site, Benidorm Alicante, , Spain

Sandoz Investigational Site, Bilbao, , Spain

Sandoz Investigational Site, Donostia-San Sebastián, , Spain

Sandoz Investigational Site, La Rioja, , Spain

Sandoz Investigational Site, Lorca, , Spain

Sandoz Investigational Site, Pamplona, , Spain

Sandoz Investigational Site, Valencia, , Spain

Sandoz Investigational Site, Vitoria-Gasteiz, , Spain

Sandoz Investigational Site, Genolier, , Switzerland

Sandoz Investigational Site, Zurich, , Switzerland

Sandoz Investigational Site, Cottingham, , United Kingdom

Sandoz Investigational Site, Liverpool, , United Kingdom

Sandoz Investigational Site, Rotherham, , United Kingdom

Sandoz Investigational Site, Scunthorpe, , United Kingdom

Contact Details

Name: Sandoz GmBH

Affiliation: Sandoz GmbH

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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