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ACTIVE NOT RECRUITING
NCT02089100
PHASE3

Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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

RADIATION

stereotactic body radiation therapy

RADIATION

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