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

Study acronym: STEREO-SEIN
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Jun 2025 to Oct 2033v9 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 280 to confirmed 154
    • Study sites: 1 to 18
    • Study completion date: Feb 2026 to Oct 2034
    • Start date: Feb 2014 to Feb 26, 2014
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Primary completion date: Feb 2020 to Jun 2025
    • Study completion date: Feb 2023 to Feb 2026
    • Site contact updated
    • Eligibility criteria shortened, about 2 words
    v8
  3. Eligibility criteria shortened, about 6 words
    • Site details revised
    v7
  4. Primary completion date: Feb 2017 to Feb 2020
    • Study completion date: Feb 2020 to Feb 2023
    v6
  5. 2 versions Re-verified since Jun 8, 2016, no change to tracked fieldsv4-v5
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  1. Eligibility criteria expanded, about 15 wordsv3
  2. Eligibility criteria shortened, about 12 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT02089100
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov