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Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis (CSI ProLong)

Primary Purpose

Leptomeningeal Metastasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CSI
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Craniospinal proton radiotherapy

Arm Description

30 Gy in 10 fractions to CNS

Outcomes

Primary Outcome Measures

CNS control
local control

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2023
Last Updated
February 28, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05746754
Brief Title
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Acronym
CSI ProLong
Official Title
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Craniospinal proton radiotherapy
Arm Type
Experimental
Arm Description
30 Gy in 10 fractions to CNS
Intervention Type
Radiation
Intervention Name(s)
CSI
Intervention Description
30 Gy in 10 fractions to CNS
Primary Outcome Measure Information:
Title
CNS control
Description
local control
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
actuarial
Time Frame
1 year
Title
CNS-PFS dependent on tumor site
Description
progression free survival, actuarial
Time Frame
1 year
Title
Symptomatology
Description
New symptoms, CTC AE 5.0 grade >=3
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Jensen, PhD
Phone
+45 78 45 64 00
Email
kennjens@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Dorte Winther, M.H.Sc.
Phone
+45 78 45 64 00
Email
dorte.skriver.winther@auh.rm.dk
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Phone
+45 78 45 64 00
Email
kennjens@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

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