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Radiation Therapy

Single-Fraction Radiation for Spine Lesions

Phase 1
Waitlist Available
Led By Yoshiya Yamada, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KPS ≥ 60%
Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
Must not have
Patients with circumferential epidural disease
Patients with intradural or intramedullary lesions, or lesions with < 2mm distance from tumor to spinal cord
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if single-fraction radiation therapy can help patients with spine and cauda equina lesions that have progressed after initial radiation therapy.

Who is the study for?
This trial is for adults over 18 with non-blood related cancers that have spread to the spine or cauda equina and worsened after previous radiation. They must have had prior radiation at least 6 months ago, a KPS score of at least 60%, and their cancer should be confirmed by pathology review. Excluded are those with less than a six-month life expectancy, certain blood count issues, recent bevacizumab treatment, specific spinal conditions, planned chemotherapy around re-irradiation time, inability to undergo imaging tests required for the study or if they're pregnant.
What is being tested?
The trial is testing single-fraction stereotactic radiosurgery on patients whose spine lesions from cancer have progressed despite earlier radiation therapy. It uses advanced imaging like MRI/CT for guidance and will explore three different doses to find out which one is safe and effective.
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, nausea, inflammation of surrounding tissues or organs due to high-dose radiation exposure. There might also be risks associated with sedation needed for some procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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My cancer diagnosis has been confirmed by a pathology review.
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I had radiation therapy in the same area where I'm now planned for a focused re-irradiation, at least 6 months ago.
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My spinal tumor has grown or worsened on recent scans.
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My target lesion for re-irradiation is smaller than 2 vertebral bodies.
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I am 18 years old or older.
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My cancer has spread to my spine or lower back and can be treated with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread around my spinal cord.
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My tumor is very close to or inside my spinal cord.
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My spinal cord has received less than 100 Gy of radiation in total.
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My cancer has spread near my spine but not to the lower spine or sacral area.
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My blood does not clot properly, and I can't safely stop my blood thinners for the procedure.
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My treatment plan does not exceed safe radiation levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria
Secondary study objectives
local failure
overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: single-fraction radiosurgeryExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,719 Total Patients Enrolled
Yoshiya Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
368 Total Patients Enrolled

Media Library

Single-fraction radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02278744 — Phase 1
Spine Lesions Research Study Groups: single-fraction radiosurgery
Spine Lesions Clinical Trial 2023: Single-fraction radiation Highlights & Side Effects. Trial Name: NCT02278744 — Phase 1
Single-fraction radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02278744 — Phase 1
~1 spots leftby Oct 2025
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