Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CSI.
- Who it may be relevant to
- Registry conditions: Leptomeningeal Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Overview
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.
Interventions
- Radiation CSI
30 Gy in 10 fractions to CNS
Primary outcome measures
- CNS control [Time frame: 6 months]
Secondary outcome measures (3)
- overall survival [Time frame: 1 year]
- CNS-PFS dependent on tumor site [Time frame: 1 year]
- Symptomatology [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Department of Oncology, Aalborg University Hospital — Aalborg
Identifiers
NCT: NCT05746754 · CSI ProLong