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
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: stereotactic body radiation therapy
Radiation: Systemic treatment
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 280
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089100

Contacts
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

Locations
France
Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Cedric Parlavecchio    0142113861 ext +33    cedric.parlavecchio@gustaveroussy.fr   
Principal Investigator: Céline Bourgier, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Céline BOURGIER, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02089100     History of Changes
Other Study ID Numbers: 2013-A00142-43, 2013/1957
Study First Received: March 13, 2014
Last Updated: March 14, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014