Actively Recruiting
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Led by University of Aarhus · Updated on 2025-04-06
50
Participants Needed
2
Research Sites
386 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal metastasis is a rare but serious complication to cancer, with a grave prognosis. No efficient treatment exists. 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
CONDITIONS
Official Title
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastasis to the leptomeningeal space surrounding the brain and/or spinal cord
- Metastasis confirmed by MRI or cerebrospinal fluid cytology
- Karnofsky performance status 60 or higher (able to care for most personal needs with some help)
- Adequate bone marrow function with haemoglobin > 5 mmol/l, absolute neutrophil count >1 x10^9/l, and platelet count > 100 x10^9/l
- Patient provides consent to participate
- Female patients must be of non-reproductive potential (age 60 or older, no menses for over 1 year without other cause, or history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have a pregnancy test within 2 weeks before treatment
- Patients with reproductive potential must agree to use effective contraception
You will not qualify if you...
- Previous radiotherapy to the treatment area that prevents safe planning respecting normal tissue limits
- Multiple serious major neurological deficits including encephalopathy as assessed by physician
- Extensive systemic disease without reasonable systemic treatment options
- Inability to undergo MRI of brain and spine with gadolinium contrast
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8000
Actively Recruiting
2
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
Research Team
K
Kenneth Jensen, PhD
CONTACT
D
Dorte Winther, M.H.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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