Leptomeningeal MetastasisCSI ProLongNCT05746754
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
A study testing CSI in people with Leptomeningeal Metastasis, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- CSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2023to 1 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Oncology, Aalborg University Hospital
Aalborg, 9000
Weronoka Szejniuk, MD
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus, 8000
Kenneth Jensen, MD, +45 78 45 64 00, kennjens@rm.dk
About this study
Official title: Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
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
Read the 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
- Being tested
- CSI
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSIRadiation
30 Gy in 10 fractions to CNS
| Study group | Role | What they receive |
|---|---|---|
| Craniospinal proton radiotherapy | Experimental | 30 Gy in 10 fractions to CNS Receives: Radiation: CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS control
local control
Measured: 6 months
Secondary outcomes (3)
overall survival
actuarial
Measured: 1 year
CNS-PFS dependent on tumor site
progression free survival, actuarial
Measured: 1 year
Symptomatology
New symptoms, CTC AE 5.0 grade >=3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Nov 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746754
- Sponsor's protocol ID
- CSI ProLong
- Acronym
- CSI ProLong
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT05746754
- Acronym / sponsor ID
- CSI ProLong / CSI ProLong
- Conditions
- Leptomeningeal Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Craniospinal proton radiotherapy | Experimental | Radiation: CSI30 Gy in 10 fractions to CNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Patient consent
Key exclusion criteria (5 listed)
- • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSI30 Gy in 10 fractions to CNS | Radiation | Craniospinal proton radiotherapy |
Primary outcome
CNS control
Time frame: 6 months
local control
3 secondary outcomes
overall survival
Time frame: 1 year
CNS-PFS dependent on tumor site
Time frame: 1 year
Symptomatology
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSI in people with Leptomeningeal Metastasis, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Jensen, PhD (+45 78 45 64 00, kennjens@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.