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Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery

NCT02278744 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-11-04

No results posted yet for this study

Summary

This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.

Conditions

  • Metastatic Spine Lesions

Interventions

RADIATION

single-fraction radiation

Patients enrolled on this study will be registered into a dose tier and undergo 1 session of image-guided SRS using techniques previously. Three escalating SRS spinal cord/cauda maximum dose (Dmax) levels (14 Gy, 16 Gy, and 17 Gy) will be evaluated to determine the safety of this approach. A minimum of three patients will be treated per dose tier. Toxicity based on NCI CTCAE (v4). Post treatment followup at 2 and 4 months (+/- 2 weeks) post-treatment, at 6 months (+/- 4 weeks) and then every 3 months until 2 years (± 4 weeks). Followup schedule based on last day of treatment. No schedule adjustments based on early or delayed visits.

DEVICE

MRI and/or CT

Sponsors & Collaborators

Principal Investigators

  • Yoshiya Yamada, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-27
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278744 on ClinicalTrials.gov