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NCT02320825

Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

Completed Phase 3 Results posted Last updated 19 February 2019
What this trial tests

Phase 3 trial testing single-fraction SRS in Spinal Metastases in 16 participants. Completed in 26 July 2018.

Timeline
16 December 2014
Primary endpoint
26 July 2018
26 July 2018

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date16 December 2014
Primary completion26 July 2018
Estimated completion26 July 2018
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Spinal Metastases. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High-dose Hypofractionated SRS (27 Gy in 3 Fractions)
Serious: 1/8 (13%)
Deaths: 7/8
Single-fraction SRS (24 Gy)
Serious: 0/8 (0%)
Deaths: 5/8

Serious adverse events (1 terms)

ReactionSystemHigh-dose Hypofractionated…Single-fraction SRS (24 Gy)
EsophagitisGastrointestinal disorders

Most-reported serious reactions: Esophagitis.

Data from ClinicalTrials.gov NCT02320825 adverse events section.

Sponsor's own description

The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation.
    Huo M, Sahgal A, Pryor D, Redmond K, et al · · 2017 · cited 37× · PMID 28303210 · DOI 10.4103/2152-7806.200581
  2. Racial, ethnic, and socioeconomic disparities in clinical trial reporting for metastatic spine tumors: An exploration of North American studies.
    Bangash AH, Fluss R, Eleswarapu AS, Fourman MS, et al · · 2025 · PMID 39969615 · DOI 10.1007/s10143-025-03343-1

Verify or expand the search:

Other recruiting trials for Spinal Metastases

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02320825.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing