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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

stereotactic body radiation therapy

Systemic treatment

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy proven breast cancer stage IV AJCC TNM
Age >18 years
WHO status</=2
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:

More than 3 consecutive and contagious spinal segments involved by tumor
Neurological examination prior randomization > 1 week
Inability to tolerate treatment (unable to lie flat)
Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
Significant or progressive neurological deficit
More than 25% spinal canal compromise
Malignant epidural spinal cord compression or cauda equina syndrome
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

Sites / Locations

Gustave Roussy Cancer Campus Grand ParisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stereotactic body radiation therapy

no specific treatment

Arm Description

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 to the oligometastatic sites except for palliation (pain, compression, hemorrhage)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cumulative rate of local failure

assessed with RECIST1.1 criteria

Overall survival

Full Information

NCT ID

NCT02089100

First Posted

March 13, 2014

Last Updated

July 20, 2018

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT02089100

Brief Title

Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

Acronym

STEREO-SEIN

Official Title

Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stereotactic body radiation therapy

Arm Type

Experimental

Arm Description

Arm Title

no specific treatment

Arm Type

Active Comparator

Arm Description

no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage)

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation therapy

Intervention Type

Radiation

Intervention Name(s)

Systemic treatment

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

evaluated with a minimal follow-up of 3 years in all patients

Secondary Outcome Measure Information:

Title

Cumulative rate of local failure

Description

assessed with RECIST1.1 criteria

Time Frame

evaluated with a minimum follow-up of 3 years in all patients.

Title

Overall survival

Time Frame

evaluated with a minimum follow-up of 3 years in all patients

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proven breast cancer stage IV AJCC TNM Age >18 years WHO status</=2 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: adequate liver function (liver enzyme <3N, bilirubin<30mg/dl, albumin>2.5g/dl) no underlying cirrhosis or hepatitis liver metastase size </=7cm diameter not adjacent to stomach or small bowel 10. For abdominal mets: 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: More than 3 consecutive and contagious spinal segments involved by tumor Neurological examination prior randomization > 1 week Inability to tolerate treatment (unable to lie flat) Treated with radionuclide/systemic chemotherapy within 30 days before SBRT Significant or progressive neurological deficit More than 25% spinal canal compromise Malignant epidural spinal cord compression or cauda equina syndrome 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Céline BOURGIER, MD

Phone

04 67 61 25 19

Ext

+33

celine.bourgier@icm.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Cédric Parlavecchio

Phone

01 42 11 38 61

Ext

+33

cedric.parlavecchio@gustaveroussy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Céline BOURGIER, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

Gustave Roussy Cancer Campus Grand Paris

City

Villejuif

State/Province

Val De Marne

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cedric Parlavecchio

Phone

0142113861

Ext

+33

cedric.parlavecchio@gustaveroussy.fr

First Name & Middle Initial & Last Name & Degree

Céline Bourgier, MD

12. IPD Sharing Statement

Learn more about this trial

Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

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