Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer (STEREO-SEIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT02089100
First received: March 13, 2014
Last updated: March 14, 2014
Last verified: March 2014

March 13, 2014
March 14, 2014
February 2014
February 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02089100 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer
Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: stereotactic body radiation therapy
  • Radiation: Systemic 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.
    Interventions:
    • 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)
    Intervention: Radiation: Systemic treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
February 2020
February 2017   (final data collection date for primary outcome measure)

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)
  5. No Her2 overexpression breast cancer (Her2- either by IHC or FISH)
  6. The primary tumor has to have been treated with curative intent (surgery and /or radiotherapy)
  7. No prior treatment for metastatic relapse
  8. Measurable lesions on imaging without previous irradiation, except for bone disease
  9. Evidence that these lesions are metastases from breast cancer (ie biopsy not mandatory but recommended on one site)
  10. All metastatic sites except brain metastases
  11. Maximum 5 lesions, each </=10 cm or </=500 mL
  12. 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
  13. For abdominal mets:

    a. Adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min

  14. For spinal cord mets:

    1. Maximum of 2 consecutive or noncontiguous spinal segments involved by tumor
    2. Neurological examination within 1 week prior to registration to exclude patients who would have rapid neurologic decline;
  15. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule
  16. Life expectancy > 3 months
  17. Affiliated to Health Insurance regimen
  18. Written and signed consent form

Exclusion Criteria:

  1. Triple negative breast cancer
  2. Her2+++ breast cancer
  3. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide)
  4. Brain metastases
  5. In liver mets:

    a. Cirrhotic liver

  6. In spinal cord mets:

    1. Inability to tolerate treatment (unable to lie flat)
    2. Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
    3. Significant or progressive neurological deficit
    4. More than 25% spinal canal compromise
    5. Malignant epidural spinal cord compression or cauda equina syndrome
    6. Spine instability or neurological deficit resulting from bony compression of neural structures
  7. Scleroderma or connective tissue disease as a contraindication to radiotherapy
Female
18 Years and older
No
Contact: Céline BOURGIER, MD 04 67 61 25 19 ext +33 celine.bourgier@icm.unicancer.fr
Contact: Cédric Parlavecchio 01 42 11 38 61 ext +33 cedric.parlavecchio@gustaveroussy.fr
France
 
NCT02089100
2013-A00142-43, 2013/1957
No
Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Study Chair: Céline BOURGIER, MD Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP