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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
Patients must be referred from Danish Departments of Oncology with radiotherapy service.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Craniospinal proton radiotherapy | Experimental | 30 Gy in 10 fractions to CNS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSI | Radiation | 30 Gy in 10 fractions to CNS |
|
| Measure | Description | Time Frame |
|---|---|---|
| CNS control | local control | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | actuarial | 1 year |
| CNS-PFS dependent on tumor site | progression free survival, actuarial | 1 year |
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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
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Jensen, PhD | Contact | +45 78 45 64 00 | kennjens@rm.dk | |
| Dorte Winther, M.H.Sc. | Contact | +45 78 45 64 00 | dorte.skriver.winther@auh.rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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Single Group
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| Symptomatology | New symptoms, CTC AE 5.0 grade >=3 | 1 year |
| Department of Oncology, Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
|
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |