Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Recruiting now · Not applicable

Conditions studied: Leptomeningeal Metastasis

In brief

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

Key facts

Study ID

NCT05746754

Run by

University of Aarhus

People needed

50

Starts

2023-11-01

Expected to finish

2031-04-01

Last updated by the study team

2025-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• • 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.

Where it is running

• Aarhus University Hospital — Aarhus, Aarhus, Denmark (enrolling)
• Department of Oncology, Aalborg University Hospital — Aalborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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