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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

April 10, 2020

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Leptomeningeal Metastases
Interventions
RADIATION

Involved-field Photon Radiation Therapy

Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions)

RADIATION

Proton Craniospinal Irradiation (CSI)

Proton CSI (30Gy \[RBE\] in 10 fractions)

OTHER

Neurocognitive Assessment

All patients at MSKCC will complete a neurocognitive test battery at study entry (prior to RT), and approximately 3, 6 and 12 months and post -RT. The neurocognitive tests consists of standardized, validated and reliable measures of attention, executive functions, and memory, for which age- and education-matched healthy control published data are available. Patients will also complete self-report mood and fatigue scales at each of the same time points. This testing will only be done at MSKCC. Non-English-speaking patients and pediatric patients are exempt from completing the neurocognitive assessments. Neurocognitive assessments will be performed in person at MSK-Manhattan; an option to perform follow up assessments via telehealth will be available only for patients who are not able to go to Manhattan for these visits.

OTHER

MDASI-BT and MDASI-SP

Using MDASI-BT and MDASI-SP questionnaires before, weekly during, at 3 months (+/- 4 weeks), 6 months (+/- 4 weeks), 9 months (+/- 4 weeks), and 12 months (+/- 4 weeks) after group assignment, and at CNS disease progression. Only one set needs to be completed. Non-English-speaking patients and pediatric patients are exempt from completing the patient-reported outcomes unless translated PRO assessment forms are available. Questionnaires will be completed via mail, in-person, or online (MSK Engage).

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limitedl protocol activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
collaborator

Fred Hutchinson Cancer Center

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER