Study

EORTC-1945

Stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers (OligoRARE): a randomized, phase 3, open-label trial.

Trial Status

Recruiting

Dates

Date of activation: 10-Jun-2021

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 200 - All Groups: 200

Treatment

Radiotherapy

Study Staff

  • Matthias Guckenberger (Study Coordinator), UniversitaetsSpital Zurich, Zurich
  • Piet Ost (Study Coordinator), GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Enrico Clementel (QART Manager), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Coreen Corning (QART Manager), EORTC Headquarters, Brussels
  • Shani De Coster (Data Manager), EORTC Headquarters, Brussels
  • Ruxandra Dionisie (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Nathalie Elaut (Study Designer), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Irina Ghislain (QoL Specialist), EORTC Headquarters, Brussels
  • Leslie Herman (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Volha Hertsyk (RTQA Fellow), EORTC Headquarters, Brussels
  • Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
  • Eleni Mandila (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Felix Oppong (Statistician), EORTC Headquarters, Brussels
  • Davide Passariello (Project Manager), EORTC Headquarters, Brussels
  • Valentina Pomella (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Corinne Sokeng (Statistical Analyst), EORTC Headquarters, Brussels
  • Luiza Souza (QART Manager), EORTC Headquarters, Brussels
  • Maarten Spruyt (Study Designer), EORTC Headquarters, Brussels
  • Eliza Starczewska (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Christine de Balincourt (Lead CRA), EORTC Headquarters, Brussels

Type of cancer

  • Head and Neck
  • Melanoma
  • Soft Tissue and Bone Sarcoma
  • Solid Tumors, Unspecified
  • Thyroid
  • Renal

Participating groups

Recruiting centers

  • Centre Oscar Lambret (LILLE CEDEX, France)
  • GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • Inselspital (Bern, Switzerland)
  • Institut Jules Bordet (Anderlecht, Belgium)
  • Istituto Europeo di Oncologia (Milano, Italy)
  • Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
  • Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
  • UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
  • UniversitaetsSpital Zurich (Zurich, Switzerland)
  • Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
  • Universitair Ziekenhuis Gent (Gent, Belgium)

Centers to be activated

  • Kliniken Maria Hilf GmbH (Moenchengladbach, Germany)
  • London Health Sciences Centre (London, Canada)
  • Medical University Of Gdansk (Gdansk, Poland)
  • Universita Di Torino - San Giovanni Battista (Torino, Italy)

Protocol summary

NCT number

NCT04498767

Study

EORTC-1945

Stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers (OligoRARE): a randomized, phase 3, open-label trial.

Research Projects

RP-2381

Investigating the application of GTV-versus PTV-based dose prescription for SBRT treatment of lung lesions