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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. Identifier: NCT02089100
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : July 23, 2018
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: stereotactic body radiation therapy Radiation: Systemic treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Cumulative rate of local failure [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients. ]
    assessed with RECIST1.1 criteria

  2. Overall survival [ Time Frame: evaluated with a minimum follow-up of 3 years in all patients ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Biopsy proven breast cancer stage IV AJCC TNM
  2. Age >18 years
  3. WHO status</=2
  4. Hormonal receptors positive breast cancer (IHC)

6. The primary tumor has to have been treated with curative intent (surgery and /or radiotherapy) 7. No prior treatment for metastatic relapse

It will be accpeted patients which would have begun a treatment in the case where:

  • Hormonotherapy </= 1 month
  • Chemotherapy </= 1 cycle 8. a. Metastatic lesions out of previous radiation field 8. b. Equal or less than 5 metastatic lesions (measurable or not) 8. c. In case of measurable lesions, each </=10 cm or </=500 mL 9. For liver mets:

    1. adequate liver function (liver enzyme <3N, bilirubin<30mg/dl, albumin>2.5g/dl)
    2. no underlying cirrhosis or hepatitis
    3. liver metastase size </=7cm diameter
    4. not adjacent to stomach or small bowel 10. For abdominal mets:
    1. Adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min 11. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 12. Life expectancy > 3 months 13. Affiliated to Health Insurance regimen 14. Written and signed consent form

Exclusion Criteria:

1. Triple negative breast cancer 3. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide) 4. Brain metastases 5. In spinal cord mets:

  1. More than 3 consecutive and contagious spinal segments involved by tumor
  2. Neurological examination prior randomization > 1 week
  3. Inability to tolerate treatment (unable to lie flat)
  4. Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
  5. Significant or progressive neurological deficit
  6. More than 25% spinal canal compromise
  7. Malignant epidural spinal cord compression or cauda equina syndrome
  8. Spine instability or neurological deficit resulting from bony compression of neural structures 6. Scleroderma or connective tissue disease as a contraindication to radiotherapy 7. Pregnancy or breast feeding period

Information from the National Library of Medicine

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 identifier (NCT number): NCT02089100

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Contact: Céline BOURGIER, MD 04 67 61 25 19 ext +33
Contact: Cédric Parlavecchio 01 42 11 38 61 ext +33

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Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Cedric Parlavecchio    0142113861 ext +33   
Principal Investigator: Céline Bourgier, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Study Chair: Céline BOURGIER, MD Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT02089100    
Other Study ID Numbers: 2013-A00142-43
2013/1957 ( Other Identifier: CSET number )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases