A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
Sponsor study identifier
interventional
9
1 country
1
Study Start
October 27, 2014
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2014
Actual (reported)October 27, 2014
Actual (reported)October 30, 2014
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria
The toxicities associated with single fraction stereotactic radiosurgery to the spine may be classified as either early (occurring within 90 days of the treatment) or late toxicities (after 90 days to 1 year). These toxicities will be evaluated with the National Cancer Institute (NCI) Common Toxicity Criteria.
1 year
local failure
1 year
overall survival
2 years
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.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Yoshiya Yamada, MD
Memorial Sloan Kettering Cancer Center
9 participants (actual enrollment reported by the registry).
First Submitted
October 27, 2014
First Posted
October 30, 2014
Study Start
October 27, 2014
Actual (reported)Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 4, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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