Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
CSI ProLong
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
1 other identifier
interventional
50
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
ExpectedApril 6, 2025
May 1, 2024
2.4 years
February 16, 2023
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
CNS control
local control
6 months
Secondary Outcomes (3)
overall survival
1 year
CNS-PFS dependent on tumor site
1 year
Symptomatology
1 year
Study Arms (1)
Craniospinal proton radiotherapy
EXPERIMENTAL30 Gy in 10 fractions to CNS
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
Department of Oncology, Aalborg University Hospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
February 28, 2023
Study Start
November 1, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2031
Last Updated
April 6, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share