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

Phase II Study of 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

Study Overview

• Status: Recruiting
• Conditions: Leptomeningeal Metastasis
• Intervention / Treatment: Radiation: CSI

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth Jensen, PhD; Phone Number: +45 78 45 64 00; Email: kennjens@rm.dk
• Study Contact Backup: Name: Dorte Winther, M.H.Sc.; Phone Number: +45 78 45 64 00; Email: dorte.skriver.winther@auh.rm.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Department of Oncology, Aalborg University Hospital
    • Contact: Weronoka Szejniuk, MD
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital
    • Contact: Kenneth Jensen, MD; Phone Number: +45 78 45 64 00; Email: kennjens@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNS control	local control	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	actuarial	1 year
Symptomatology	New symptoms, CTC AE 5.0 grade >=3	1 year
CNS-PFS dependent on tumor site	progression free survival, actuarial	1 year

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis
• Other Study ID Numbers: CSI ProLong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No