NCT05746754

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Leptomeningeal Metastasis

Interventions

Type	Name	Description
RADIATION	CSI	30 Gy in 10 fractions to CNS

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-04-01
• Completion: 2031-04-01
• First posted: 2023-02-28
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Denmark