Clinical trial · Interventional
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
NCT05746754CI-TRIAL-00088201CSI ProLongrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Craniospinal proton radiotherapy
- description
- 30 Gy in 10 fractions to CNS
- interventionNames
- Radiation: CSI
Primary outcomes (1)
- measure
- CNS control
- timeFrame
- 6 months
- description
- local control
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 1 year
- description
- actuarial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.