Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases (NCT03520504) | Clinical Trial Compass
CompletedPhase 1
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases
United States24 participantsStarted 2018-04-26
Plain-language summary
The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old and 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 negative serum pregnancy test within 2 weeks prior to starting treatment.
* Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
* KPS ≥ 60.
* Age ≥ 10 years.
* For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
* Patient at reproductive potential must agree to practice an effective contraceptive method.
* Adequate bone marrow function:
* Hemoglobin ≥ 8g/dL
* Absolute neutrophil count ≥500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Exclusion Criteria:
* Patient with multiple, serious major neurologic deficits 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.
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Pregnant or lactating women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.