Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Leptomeningeal Metastasis Clinical Trial

— CSI ProLong  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746754
• Other study ID #: CSI ProLong
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 1, 2031

Study information

• Verified date: February 2023
• Source: University of Aarhus
• Contact: Kenneth Jensen, PhD
• Phone: +45 78 45 64 00
• Email: kennjens[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We want to offer Danish patients the new treatment, but within a protocol, as this is new data with an new treatment principle

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2031
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis

Intervention

Radiation:
• CSI
30 Gy in 10 fractions to CNS

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CNS control	local control	6 months
Secondary	overall survival	actuarial	1 year
Secondary	CNS-PFS dependent on tumor site	progression free survival, actuarial	1 year
Secondary	Symptomatology	New symptoms, CTC AE 5.0 grade >=3	1 year