Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

Completed · Phase 2

Conditions studied: Leptomeningeal Metastases

In brief

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.

Key facts

Study ID: NCT04343573
Run by: Memorial Sloan Kettering Cancer Center
People needed: 102
Starts: 2020-04-10
Expected to finish: 2026-02-25
Last updated by the study team: 2026-02-27

Who can join

Age: any, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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
Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
Pregnant or lactating women.

Where it is running

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limitedl protocol activities) — Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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