NCT04343573CompletedPhase 2
Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors
A Phase II Randomized Study Assessing the Efficacy of Proton Craniospinal Irradiation (CSI) vs Involved-field Photon Radiation Therapy for Leptomeningeal Metastases From Solid Tumor Malignancies
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 10 Apr 2020
- Start date
- 10 Apr 2020
- Primary completion date
- 25 Feb 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT04343573
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 102
- From 10 Apr 2020 to the primary completion date, 25 Feb 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
Other illness
- Patient with extensive systemic disease and without reasonable systemic treatment options
Other
- Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- Patient who is unable to undergo MRI brain and spine with gadolinium contrast
- Pregnant or lactating women.
Who the study is looking for
- Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology
- Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
- Patients of all ages
- KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants \< 16 years old
- For adult patient, the patient/ legally authorized representative is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
- Adequate bone marrow function:
- Hemoglobin \> 8g/dL
- Absolute neutrophil count \>1,000/mm
- Platelet count \> 100,000/mm
- Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history \[≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
- Patient at reproductive potential must agree to practice an effective contraceptive method.
Age in the registry: - to 99 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack (Limited protocol activities) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Limitedl protocol activities) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.