Proton therapy for leptomeningeal metastasis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain-avoiding proton craniospinal irradiation for leptomeningeal metastases

  This study tests BRAVO pCSI, a proton therapy approach that avoids certain brain regions, to see if it helps adults with leptomeningeal metastases from solid tumors.

  Recruiting University of Miami · Miami, Florida · NCT07789912

• Double-dose third-generation EGFR-TKI with bevacizumab and intrathecal chemotherapy for leptomeningeal NSCLC

  This trial will try whether giving a double dose of a third-generation EGFR-TKI together with bevacizumab and spinal (intrathecal) chemotherapy can help people with EGFR-mutant NSCLC whose leptomeningeal metastasis progressed after a standard-dose third-generation EGFR-TKI.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07398599

• Pulsatile high-dose furmonertinib for EGFR-mutant NSCLC with leptomeningeal metastasis

  This tests whether taking high-dose furmonertinib every other day helps people with EGFR-mutant non-small cell lung cancer that has spread to the leptomeninges.

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• Multiple intraventricular doses of rhenium‑186 nanoliposome for leptomeningeal metastases

  This trial will test whether giving multiple intraventricular doses of a rhenium‑186 nanoliposome is safe and could help adults with leptomeningeal metastases from solid tumors.

  Recruiting Phase 1/2 Cerenome · San Antonio, Texas · NCT07098806

• High-dose firmonertinib plus chemotherapy injected into the spinal fluid for EGFR-mutant NSCLC with leptomeningeal spread

  This tests whether high-dose firmonertinib combined with chemotherapy injected into the spinal fluid helps people with EGFR-mutant non-small cell lung cancer that has spread to the leptomeninges.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07092202

• Treatment of refractory non-squamous non-small cell lung cancer with leptomeningeal metastases using Pemetrexed and Nivolumab injections

  This study is testing if a combination of Pemetrexed and Nivolumab injections can help people with tough-to-treat lung cancer that has spread to the protective layers around the brain.

  Recruiting Phase 2 Shanghai Cancer Hospital, China · Shanghai, Shanghai Municipality · NCT06901817

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.