Study

EORTC-1559-HNCG

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 Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 16-Nov-2017
Date Step1 close: 04-Jul-2023

Data management at EORTC

Yes

Design

Phase 2
Randomized open label

Treatment

Drug
Fluorouracil, Bleomycin, Carboplatin, Docetaxel, Gemcitabine, Methotrexate, Mitomycin, Paclitaxel, Afatinib, Niraparib, Palbociclib, Durvalumab, Monalizumab, Rogaratinib, INCAGN01876, Retifanlimab

Study Staff

  • Jean-Pascal Machiels (Study Coordinator), Cliniques Universitaires Saint-Luc, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Lieve Dirix (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
  • Rachel Galot (Study Co-Coordinator), Cliniques Universitaires Saint-Luc, Brussels
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
  • Gracia Katanga (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Stephanie Kromar (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Ellen Peeters (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Arnaud Poncin (Data Manager), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Bette Stofs (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Konstantina Tsechilidou (Data Manager), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Egle Venslovaite (Project Manager), EORTC Headquarters, Brussels
  • Yuliya Vostrikova (Data Manager), EORTC Headquarters, Brussels
  • Xiao Mang Zhou (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Athenais van der Elst (Fellow), 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)
  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
  • 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 CEDEX, France)
  • Centre Antoine Lacassagne (NICE CEDEX 2, France)
  • Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
  • Centre Oscar Lambret (LILLE CEDEX, France)
  • Centre de Radiotherapie Pierre Curie (Beuvry, France)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • 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)
  • ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
  • IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
  • Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
  • Institut Jules Bordet (Anderlecht, Belgium)
  • Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
  • Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France)
  • Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
  • NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
  • Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
  • U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
  • Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
  • Universitair Ziekenhuis Gent (Gent, Belgium)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT03088059

NCT number

NCT03088059

EudraCT

2017-000086-74