RecruitingNot ApplicableNCT05746754

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

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

Sponsor

University of Aarhus

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Leptomeningeal Metastasis

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

Min Age: 18 Years

Inclusion Criteria10

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 Criteria5

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.

Interested in this trial?

Get notified about updates and connect with the research team.