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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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).
Institut Jules Bordet
Anderlecht, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
RECRUITINGGasthuiszusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium
RECRUITINGCentre Oscar Lambret
Lille, France
RECRUITINGGustave Roussy
Villejuif, France
RECRUITINGUniversitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Martinistrasse 52, Germany
RECRUITINGIstituto Europeo di Oncologia
Milan, Italy
RECRUITINGMedical University Of Gdansk
Gdansk, Mariana Smoluchowskiego 17, Poland
RECRUITINGMaria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
RECRUITINGInselspital
Bern, Switzerland
RECRUITING...and 3 more locations
Overall survival
Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.
Time frame: 7.5 years from first patient in
Progression-free survival
Time frame: 9 years from first patient in
Disease-specific survival
Time frame: 9 years from first patient in
Time to disease progression
Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.
Time frame: 9 years from first patient in
Time to development of new metastatic lesions
Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events: * Development new metastatic lesions, * Cancer-related death.
Time frame: 9 years from first patient in
Time to development of polymetastatic disease
Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events: * Presence of more than 5 metastases at a specific timepoint during follow-up, * Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible), * Cancer-related death.
Time frame: 9 years from first patient in
Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: 9 years from first patient in
Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires
Time frame: 9 years from first patient in
Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires
Time frame: 9 years from first patient in
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