Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Trial Title: Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

NCT ID: NCT05746754

Condition: Leptomeningeal Metastasis

Conditions: Official terms:
Neoplasm Metastasis
Meningeal Carcinomatosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single Group

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: CSI
Description: 30 Gy in 10 fractions to CNS
Arm group label: Craniospinal proton radiotherapy

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Oncology, Aalborg University Hospital

Address:
City: Aalborg
Zip: 9000
Country: Denmark

Status: Recruiting

Contact:
Last name: Weronoka Szejniuk, MD

Facility:
Name: Aarhus University Hospital

Address:
City: Aarhus
Zip: 8000
Country: Denmark

Status: Recruiting

Contact:
Last name: Kenneth Jensen, MD

Phone: +45 78 45 64 00
Email: kennjens@rm.dk

Start date: November 1, 2023

Completion date: April 1, 2031

Lead sponsor:
Agency: University of Aarhus
Agency class: Other

Source: University of Aarhus

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05746754