Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
NCT ID: NCT05746754
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-11-01
2031-04-01
Brief Summary
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Recent data suggest that craniospinal radiotherapy lead to superior survival and CNS control compared to focal photon radiotherapy. We want to offer Danish patients the new treatment, but within a protocol, as this is new data with an new treatment principle
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Detailed Description
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Patients with leptomeningeal metastasis from both solid and hematological cancers will be offered proton radiotherapy with 30 Gy in 10 fractions to the entire craniospinal axis. Patients will be followed with registration of side effects, neurology and MRI scans every 3 months until 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Craniospinal proton radiotherapy
30 Gy in 10 fractions to CNS
CSI
30 Gy in 10 fractions to CNS
Interventions
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CSI
30 Gy in 10 fractions to CNS
Eligibility Criteria
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Inclusion Criteria
* Metastasis verified by MRI or CSF cytology
* Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
* Adequate bone marrow function
* Haemoglobin \> 5 mmol/l
* Absolute neutrophil count \>1 10\^9/l
* Platelet count \> 100 10\^9/l
* Patient consent
* Female subjects must either be of non-reproductive potential ( ≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a pregnancy test within 2 weeks prior to starting treatment.
* Patient at reproductive potential must agree to practice an effective contraceptive method.
Exclusion Criteria
* Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
* Patient with extensive systemic disease and without reasonable systemic treatment options
* Patient who is unable to undergo MRI brain and spine with gadolinium contrast
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Aarhus, Denmark
Department of Oncology, Aalborg University Hospital
Aalborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Weronoka Szejniuk, MD
Role: primary
Other Identifiers
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CSI ProLong
Identifier Type: -
Identifier Source: org_study_id
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