Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
ConditionLeptomeningeal Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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
Eligibility criteria
Qualifiers
Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
Metastasis verified by MRI or CSF cytology
Karnofsky >=60 (requiring some help, can take care of most personal requirements)
Adequate bone marrow function
Disqualifiers
• Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)
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
Trial design
Treatments tested in this trial
- CSI
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov