Proton therapy for leptomeningeal metastasis treatment
Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
This study is testing if proton therapy can help people with leptomeningeal metastasis, a serious cancer complication, feel better and manage their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus, Aarhus and 1 other locations) |
| Trial ID | NCT05746754 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of proton craniospinal irradiation in patients with leptomeningeal metastasis, a serious complication of cancer. Patients will receive a total dose of 30 Gy delivered in 10 fractions targeting the entire craniospinal axis. The study will involve close monitoring of side effects, neurological status, and MRI scans every three months for up to one year. Participants will be referred from Danish oncology departments, ensuring a structured approach to treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed leptomeningeal metastasis from solid or hematological cancers who have adequate bone marrow function and a Karnofsky score of 60 or higher.
Not a fit: Patients who have previously received radiotherapy to the treatment site that limits the development of a safe treatment plan will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and central nervous system control for patients with leptomeningeal metastasis.
How similar studies have performed: While this approach is based on recent data suggesting improved outcomes with craniospinal radiotherapy, it represents a novel application of proton therapy for this specific condition.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus, Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus, Aarhus, Denmark (Recruiting)
- Department of Oncology, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Kenneth Jensen, PhD
- Email: kennjens@rm.dk
- Phone: +45 78 45 64 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.