Trial reportBMC cancer2020
Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial.
Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03696680 (Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Who cites it
10 citing papers in PubMed, 11 citations in OpenAlex.
- Tailored management of a melanoma patient with bleeding brain metastases and deep vein thrombosis with thrombectomy.CNS oncology · 2026Article
- Improving differentiation of hemorrhagic brain metastases from non-neoplastic hematomas using radiomics and clinical feature fusion.Neuroradiology · 2025Article
- Management of anticoagulation in patients with brain metastasis.Hematology. American Society of Hematology. Education Program · 2024Review
- Article
- Evaluating the Efficacy of Machine Performance Checks as an Alternative to Winston-Lutz Quality Assurance Testing in the TrueBeam Linear Accelerator with HyperArc.Diagnostics (Basel, Switzerland) · 2024Article
- Should we be afraid of radiotherapy for hemorrhagic brain metastases? A narrative review.Therapeutic advances in medical oncology · 2024Review
- Article
- Preoperative Metastatic Brain Tumor-Associated Intracerebral Hemorrhage Is Associated With Dismal Prognosis.Frontiers in oncology · 2021Article
- Integrating multimodal management and molecular profiling in a patient with BRAF V600E-positive melanoma and brain metastases.CA: a cancer journal for cliniciansArticle
- Outcomes of patients with melanoma brain metastases treated with ipilimumab and nivolumab with or without upfront comprehensive stereotactic radiosurgery.Neuro-oncology advancesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundBrain metastases often occur in cancer evolution. They are not only responsible for death but also for disorders affecting the quality of life and the cognitive functions. Management of brain metastases usually consists in multi-modality treatments, including neurosurgery, whole brain radiotherapy (WBRT), and more recently radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT), systemic treatment (chemotherapy or targeted therapy), combined or not with corticosteroids. Almost 20% of brain metastases can present recent (within 15 days) bleeding signs on neuro-imagery. In these conditions, WBRT is the usual treatment. Yet, patients may benefit from a more aggressive strategy with SRT or FSRT. However, these options were suspected to possibly major the risk of brain haemorrhage, although no scientifically proven. Radiation oncologists therefore usually remain reluctant to deliver SRS/FSRT for bleeding brain metastases. It is therefore challenging to establish a standard of care for the treatment of bleeding brain metastases. We propose a phase II trial to simultaneously assess safety and efficacy of FSRT to manage brain metastases with hemorrhagic signal.
methodsThe STEREO-HBM study is a multicenter two-step non-randomised phase II trial addressing patients with at least one bleeding brain metastasis out of a maximum of 3 brain metastases. Each brain metastasis will be treated with 30 Gy in 3 fractions for 1 week. The main endpoint is based on both safety and efficacy endpoints as proposed by Bryant and Day's design. Safety endpoint is defined as the rate of bleeding complications 4 months post-FSRT while efficacy endpoint is defined as the 6-month local control rate. Multi-modal MRI will be used to assess intra-tumoral hemorrhagic events before and after treatment. Patients' quality of life will also be assessed. DISCUSSION: Management of bleeding brain metastases is still debated and poorly explored in clinical trials. There is sparse and weak data on the signification of pretreatment intra-tumour haemorrhagic signs or on the risk of brain bleeding complications after FSRT. We expect this first prospective phase 2 trial in this particular setting will allow to clarify the place of FSRT to optimally manage bleeding brain metastases.
trial registrationNCT03696680, registered October, 4, 2018. PROTOCOL VERSION: Version 2.1 dated from 2018/11/09.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.