Health TrialsbyHealthPanel

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

ConditionLeptomeningeal Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • CSI

    Radiation

    30 Gy in 10 fractions to CNS

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Craniospinal proton radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CNS control

local control

Time frame
6 months

Secondary outcomes

1

overall survival

actuarial

Time frame
1 year
2

CNS-PFS dependent on tumor site

progression free survival, actuarial

Time frame
1 year
3

Symptomatology

New symptoms, CTC AE 5.0 grade \>=3

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov
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