Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Study summary
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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — evaluated with a minimal follow-up of 5 years in all patients
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.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne | |
| 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 | |
| Centre Eugène Marquis | Rennes | France | |
| Henri Becquerel | Rouen | France | |
| Institut de cancérologie de l'Ouest René Gauducheau | Saint-Herblain | France | |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France | |
| Centre de Cancérologie Paris Nord | Sarcelles | France | |
| Centre de Radiothérapie de la Robertsau | Strasbourg | France | |
| Centre Paul Strauss | Strasbourg | France | |
| Hôpital Bretonneau | Tours | France |
More Gustave Roussy, Cancer Campus, Grand Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02089100 on ClinicalTrials.gov ↗ ← All trials in France