CSI
Radiation30 Gy in 10 fractions to CNS
NCT Number: NCT05746754
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Aarhus University Hospital, Aarhus, Denmark
Patients must be referred from Danish Departments of Oncology with radiotherapy service.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 Gy in 10 fractions to CNS
Time frame: 6 months
local control
Time frame: 1 year
actuarial
Time frame: 1 year
progression free survival, actuarial
Time frame: 1 year
New symptoms, CTC AE 5.0 grade >=3
Contact information is provided by the study sponsor or research team.
Dorte Winther, M.H.Sc.
CONTACT
Kenneth Jensen, PhD
CONTACT
University of Aarhus
Other
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Acronym: CSI ProLong
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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