Study

EORTC-62113-55115-STBSG-GCG

A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 30-Jan-2015

Data management at EORTC

Yes

Design

Phase 2
Randomized blind

Targeted Sample size

EORTC Groups: 85 - All Groups: 115

Treatment

Drug
Cabozantinib, Blind trial medication-62113

Study Staff

  • Isabelle Ray Coquard (Study Coordinator), Centre Leon Berard, Lyon
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Laura De Meulemeester (Unblinded COM), EORTC Headquarters, Brussels
  • Catherine Fortpied (Unblinded statistician), EORTC Headquarters, Brussels
  • Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
  • Zara Nasir (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Felix Oppong (Statistician), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Carla Sureda (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Katheline Vander Heggen (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Xiao Mang Zhou (Junior RAM), EORTC Headquarters, Brussels

Type of cancer

  • Uterine

Participating groups

  • EORTC Gynecological Cancer Group
  • EORTC Soft Tissue and Bone Sarcoma Group
  • National Cancer Research Institute - Gyneco Cancer Group
  • National Cancer Research Institute - Sarcoma Group

Recruiting centers

  • Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
  • Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
  • Centre Leon Berard (Lyon, France)
  • Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
  • Hospital Universitario San Carlos (Madrid, Spain)
  • IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
  • Institut Bergonie (Bordeaux, France)
  • Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
  • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
  • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
  • Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
  • Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
  • Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
  • Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
  • University College Hospital (London, United Kingdom)

Protocol summary

http://clinicaltrials.gov/study/NCT01979393

NCT number

NCT01979393

EudraCT

2013-000762-11