NCT02089100

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
103mo left

Started Feb 2014

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Feb 2014Oct 2034

Study Start

First participant enrolled

February 26, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2033

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2034

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

19.6 years

First QC Date

March 13, 2014

Last Update Submit

March 17, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Cumulative rate of local failure

    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

Study Arms (2)

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.

Radiation: stereotactic body radiation therapyRadiation: Systemic treatment

no specific treatment

ACTIVE COMPARATOR

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

Radiation: Systemic treatment

Interventions

stereotactic body radiation therapyRADIATION
stereotactic body radiation therapy
Systemic treatmentRADIATION
no specific treatmentstereotactic body radiation therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)"

You may not qualify if:

  • It will be accepted patients which would have begun new line of systemic treatment in the case where:
  • Hormonotherapy or CDK4/6 inhibitors ≤ 3 months.
  • Chemotherapy or immunotherapy ≤ 2 cycles. If SBRT arm: The treatment (except hormonotherapy by aromatase inhibitor and/or LHRH agonist) must be interrupted during the completion of radiotherapy.
  • 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:
  • 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 9. For abdominal 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
  • Triple negative breast cancer
  • Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide)
  • Brain metastases
  • In spinal cord mets:
  • More than 3 consecutive and contiguous spinal segments involved by tumor
  • Neurological examination prior randomization \>1 week
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hôpital Nord

Marseille, 13015, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU la Timone

Marseille, 13385, France

Location

ICM - Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Henri Becquerel

Rouen, 76000, France

Location

Institut de cancérologie de l'Ouest René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Centre de Cancérologie Paris Nord

Sarcelles, 95200, France

Location

Centre de Radiothérapie de la Robertsau

Strasbourg, 67000, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hôpital Bretonneau

Tours, 37000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RadiosurgeryNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesCombined Modality Therapy

Study Officials

  • Guillaume LOUVEL, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

February 26, 2014

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

October 1, 2034

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

FR(18)