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Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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).
Official title: Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2014-02-26
Completion Date
2034-10
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
stereotactic body radiation therapy
Systemic treatment
Locations (18)
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
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