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Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Summary
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.
Official title: Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-06-10
Completion Date
2030-02-01
Last Updated
2024-08-26
Healthy Volunteers
No
Conditions
Interventions
Stereotactic body radiotherapy
Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
Palliative RT
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
Locations (13)
Institut Jules Bordet
Anderlecht, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Gasthuiszusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium
Centre Oscar Lambret
Lille, France
Gustave Roussy
Villejuif, France
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Martinistrasse 52, Germany
Istituto Europeo di Oncologia
Milan, Italy
Medical University Of Gdansk
Gdansk, Mariana Smoluchowskiego 17, Poland
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Inselspital
Bern, Switzerland
UniversitaetsSpital Zurich
Zurich, Switzerland
University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
Birmingham, United Kingdom
Royal Marsden Hospital - site: Chelsea, London
London, United Kingdom