Status:
ACTIVE_NOT_RECRUITING
Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Fred Hutchinson Cancer Center
Conditions:
Leptomeningeal Metastases
Eligibility:
All Genders
Up to 99 years
Phase:
PHASE2
Brief Summary
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 metasta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04343573
Start Date
April 10 2020
End Date
April 1 2026
Last Update
May 14 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limitedl protocol activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725