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Clinical Trials in Denmark / NCT05746754
Recruiting Not applicable

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

NCT05746754 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-11-01
Last updated
2025-04-06

Condition(s) studied

Leptomeningeal Metastasis

Investigational drug(s) / intervention(s)

CSI

CSI: 30 Gy in 10 fractions to CNS

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * 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: * • 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 * Pregnant or lactating women.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Aarhus Recruiting
Department of Oncology, Aalborg University Hospital Aalborg Denmark Recruiting

More University of Aarhus trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05746754 on ClinicalTrials.gov ↗ ← All trials in Denmark