CSI ProLong: Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Sponsor

University of Aarhus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746754

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Leptomeningeal Metastasis	Radiation: CSI	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single GroupSingle Group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Craniospinal proton radiotherapy 30 Gy in 10 fractions to CNS	Radiation: CSI 30 Gy in 10 fractions to CNS

Arm

Intervention/Treatment

Experimental: Craniospinal proton radiotherapy

30 Gy in 10 fractions to CNS

Radiation: CSI

30 Gy in 10 fractions to CNS

Outcome Measures

Primary Outcome Measures

CNS control [6 months]
local control

Secondary Outcome Measures

overall survival [1 year]
actuarial
CNS-PFS dependent on tumor site [1 year]
progression free survival, actuarial
Symptomatology [1 year]
New symptoms, CTC AE 5.0 grade >=3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT05746754

Other Study ID Numbers:

CSI ProLong

First Posted:

Feb 28, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Meningeal Carcinomatosis

Study Results

No Results Posted as of Mar 2, 2023