The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment. The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease. This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France
Institut Sainte Catherine
Avignon, France
Centre François Baclesse
Caen, France
Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Hôpital Nord
Marseille, France
Institut Paoli Calmettes
Marseille, France
CHU la Timone
Marseille, France
ICM - Val d'Aurelle
Montpellier, France
Centre Antoine Lacassagne
Nice, France
...and 8 more locations
Progression Free Survival (PFS)
events: local recurrence, distant progression of the target metastases, any new metastasis, death of any cause The definition of progression is based on RECIST1.1 criteria. Progression is assessed locally, in any metastasis present at the time of randomization or in any newly diagnosed metastasis.
Time frame: evaluated with a minimal follow-up of 5 years in all patients
Cumulative rate of local failure
assessed with RECIST1.1 criteria
Time frame: evaluated with a minimum follow-up of 5 years in all patients.
Overall survival
Time frame: evaluated with a minimum follow-up of 5 years in all patients
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