Clinical Trial Details
EORTC-1559-HNCG
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A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (UPSTREAM)
Study documentation Publications
| Trial Status | Recruiting |
|---|---|
| Dates |
Date of activation: 16-Nov-2017 |
| Data management at EORTC | Yes |
| Design |
Phase 2 Randomized open label |
| Treatment |
Drug Afatinib, Niraparib, Palbociclib, Durvalumab, Monalizumab, Rogaratinib, INCAGN01876 |
| Study Staff |
Jean-Pascal Machiels (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Catherine Fortpied (Statistician) catherine.fortpied (at) eortc.org, EORTC Headquarters, Brussels Rachel Galot (Study Co-Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Anne-Sophie Govaerts (Clinical Scientist) anne-sophie.govaerts (at) eortc.org, EORTC Headquarters, Brussels Alessandro Gugino (Project Manager) alessandro.gugino (at) eortc.org, EORTC Headquarters, Brussels Gracia Katanga (Clinical Operations Assistant) gracia.katanga (at) eortc.org, EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at) eortc.org, EORTC Headquarters, Brussels Hafida Lmalem (Imaging Officer) hafida.lmalem (at) eortc.org, EORTC Headquarters, Brussels Marie Morfouace (Clinical Scientist) marie.morfouace (at) eortc.org, EORTC Headquarters, Brussels Carla Nell (Junior Clinical Operations Manager) carla.nell (at) eortc.org, EORTC Headquarters, Brussels Anouk Neven (Statistician) anouk.neven (at) eortc.org, EORTC Headquarters, Brussels Jean-Paul Nzanzu (Lead CRA) jean-paul.nzanzu (at) eortc.org, EORTC Headquarters, Brussels Arnaud Poncin (Data Manager) arnaud.poncin (at) eortc.org, EORTC Headquarters, Brussels Tiana Raveloarivahy (Data Manager) tiana.raveloarivahy (at) eortc.org, EORTC Headquarters, Brussels Miguel Remis (Lead CRA) miguel.remis (at) eortc.org, EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at) eortc.org, EORTC Headquarters, Brussels Sophie Schrevens (Clinical Research Associate/Monitor) sophie.schrevens (at) eortc.org, EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) bette.stofs (at) eortc.org, EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) katheline.vanderheggen (at) eortc.org, EORTC Headquarters, Brussels Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at) eortc.org, EORTC Headquarters, Brussels Tomas Verdeyen (Data Manager) tomas.verdeyen (at) eortc.org, EORTC Headquarters, Brussels Tina Verschuere (Senior Clinical Operations Manager) tina.verschuere (at) eortc.org, EORTC Headquarters, Brussels Xiao Mang Zhou (Regulatory Affairs Administrator) xiao-mang.zhou (at) eortc.org, EORTC Headquarters, Brussels Athenais van der Elst (Fellow) athenais.vanderelst (at) eortc.org, EORTC Headquarters, Brussels |
| Type of cancer | Head and Neck |
| Participating groups |
EORTC Head and Neck Cancer Group UNICANCER National Cancer Research Institute - Head & Neck Cancer Grp |
| Recruiting centers |
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy) Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) CHU Saint-Pierre-Site Porte de Hal (Brussels, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France) Centre Antoine Lacassagne (Nice, France) Centre Georges-Francois-Leclerc (Dijon, France) Centre Oscar Lambret (Lille, France) Centre de Radiotherapie Pierre Curie (Beuvry, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Gustave Roussy (Villejuif, France) Hopital De Jolimont (Haine St Paul, Belgium) IRCCS - Istituto Nazionale dei Tumori (Milano, Italy) Institut Curie- Hopital de Paris (Paris, France) Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium) Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France) Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Gent (Gent, Belgium) ZNA Middelheim (Antwerpen, Belgium) |
| Centers to be activated |
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) Colchester General Hospital (Colchester, Essex, United Kingdom) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Hospital Clinico Universitario De Valencia (Valencia, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario San Carlos (Madrid, Spain) Hospital Universitario Virgen de Valme (Sevilla, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Fondazione G. Pascale (Napoli, Italy) Istituto Europeo di Oncologia (Milano, Italy) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Ospedale San Paolo (Milano, Italy) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) UKE - University Cancer Center (Hamburg, Germany) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetsklinikum Jena (Jena, Germany) Universitaetsklinikum Koeln (Koeln, Germany) Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany) Universitaetsklinikum Ulm-Michelsberg-HNO (Ulm, Germany) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT03088059 |
| NCT number | NCT03088059 |
| EudraCT | 2017-000086-74 |