Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer (STEREO-SEIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02089100|
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : July 23, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: stereotactic body radiation therapy Radiation: Systemic treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2023|
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
- Progression Free Survival (PFS) [ Time Frame: evaluated with a minimal follow-up of 3 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.
- Cumulative rate of local failure [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients. ]assessed with RECIST1.1 criteria
- Overall survival [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|