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NCT Number: NCT05746754

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSI

Radiation

30 Gy in 10 fractions to CNS

Primary outcomes

  1. CNS control

    Time frame: 6 months

    local control

Secondary outcomes

  1. overall survival

    Time frame: 1 year

    actuarial

  2. CNS-PFS dependent on tumor site

    Time frame: 1 year

    progression free survival, actuarial

  3. Symptomatology

    Time frame: 1 year

    New symptoms, CTC AE 5.0 grade >=3

Study contacts

Contact information is provided by the study sponsor or research team.

Dorte Winther, M.H.Sc.

CONTACT

[email protected]

+45 78 45 64 00

Kenneth Jensen, PhD

CONTACT

[email protected]

+45 78 45 64 00

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: CSI ProLong

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Feb 28, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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