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Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

Study acronym: OligoBM-01
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Active, Not Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Dec 2026 to Jan 2030
    • Start date: Jun 29, 2022 to Jan 12, 2023
    • Study sites: 16 to 15
    • Study completion date: Jun 2027 to Jan 2031
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Study sites: 13 to 16
    • Eligibility criteria shortened, about 9 words
    v5
  4. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jun 2022 to Jun 29, 2022
    • Site contacts updated at 13 of 13 sites
    v4
  5. Minor Study sites: 10 to 13
    • Start date: May 2022 to Jun 2022
    • Eligibility criteria expanded, about 19 words
    v3
  6. Notable Start date: Nov 2021 to May 2022v2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.
Trial Details
NCT Number NCT05102747
Lead Sponsor Centre Francois Baclesse
Collaborators: Association de Neuro-Oncologues d'Expression Francaise
Conditions
(from sponsor)
Brain Metastasis, Oligoprogression
Related terms Brain Neoplasms
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov