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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/1957 | Other Identifier | CSET number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stereotactic body radiation therapy | Experimental | 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. |
|
| no specific treatment | Active Comparator | no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Radiation |
| ||
| Systemic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. | evaluated with a minimal follow-up of 5 years in all patients |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative rate of local failure | assessed with RECIST1.1 criteria | evaluated with a minimum follow-up of 5 years in all patients. |
| Overall survival | evaluated with a minimum follow-up of 5 years in all patients |
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Inclusion Criteria:
Biopsy proven breast cancer stage IV AJCC TNM
Age >18 years
WHO status≤2
Hormonal receptors positive breast cancer (IHC)
The primary tumor was treated or will be treated with curative intent (surgery and/or radiotherapy)"
No new treatment for metastatic relapse Prior history of adjuvant hormonotherapy or relapse under adjuvant hormonotherapy are not exclusion criteria.
It will be accepted patients which would have begun new line of systemic treatment in the case where:
a. Metastatic lesions out of previous radiation field b. Equal or less than 5 metastatic lesions (measurable or not) c. In case of measurable lesions, each ≤10 cm or ≤500 mL 8. For liver mets:
a. Adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min 10. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 11. Life expectancy > 3 months 12. Affiliated to Health Insurance regimen 13. Written and signed consent form
Non-inclusion Criteria:
Triple negative breast cancer
Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide)
Brain metastases
In spinal cord mets:
Scleroderma or connective tissue disease as a contraindication to radiotherapy
Pregnancy or breast feeding period
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume LOUVEL, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne | 94805 | France | ||
| Institut Sainte Catherine |
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| Radiation |
|
| Avignon |
| 84918 |
| France |
| Centre François Baclesse | Caen | 14076 | France |
| Georges François Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hôpital Nord | Marseille | 13015 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| CHU la Timone | Marseille | 13385 | France |
| ICM - Val d'Aurelle | Montpellier | 34298 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Henri Becquerel | Rouen | 76000 | France |
| Institut de cancérologie de l'Ouest René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | 44805 | France |
| Centre de Cancérologie Paris Nord | Sarcelles | 95200 | France |
| Centre de Radiothérapie de la Robertsau | Strasbourg | 67000 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Hôpital Bretonneau | Tours | 37000 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
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