Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer (STEREO-SEIN)
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).
Radiation: stereotactic body radiation therapy
Radiation: Systemic treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment|
- Progression Free Survival (PFS) [ Time Frame: evaluated with a minimal follow-up of 3 years in all patients ] [ Designated as safety issue: No ]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.
- Cumulative rate of local failure [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients. ] [ Designated as safety issue: No ]assessed with RECIST1.1 criteria
- Overall survival [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: stereotactic body radiation therapy
The SBRT of all metastases should start in maximum 4 weeks after randomization. Beginning of systemic treatment will take place before 2 and 7 days after SBRT completion. All metastases lesions should be treated every 48h.
|Radiation: stereotactic body radiation therapy Radiation: Systemic treatment|
Active Comparator: no specific treatment
no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage)
|Radiation: Systemic treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02089100
|Contact: Céline BOURGIER, MD||04 67 61 25 19 ext +email@example.com|
|Contact: Cédric Parlavecchio||01 42 11 38 61 ext +firstname.lastname@example.org|
|Gustave Roussy Cancer Campus Grand Paris||Recruiting|
|Villejuif, Val de Marne, France, 94805|
|Contact: Cedric Parlavecchio 0142113861 ext +33 email@example.com|
|Principal Investigator: Céline Bourgier, MD|
|Study Chair:||Céline BOURGIER, MD||Gustave Roussy, Cancer Campus, Grand Paris|