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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
Phase 3 trial testing single-fraction SRS in Spinal Metastases in 16 participants. Completed in 26 July 2018.
26 July 2018
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 16 December 2014 |
| Primary completion | 26 July 2018 |
| Estimated completion | 26 July 2018 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- single-fraction SRS
- high-dose hypofractionated SRS
- Quality of Life Measures
Conditions studied
- Spinal Metastases — all drugs for Spinal Metastases →
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.
Serious adverse events (1 terms)
| Reaction | System | High-dose Hypofractionated… | Single-fraction SRS (24 Gy) |
|---|---|---|---|
| Esophagitis | Gastrointestinal 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):
-
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 -
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:
- PubMed search for NCT02320825
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spinal Metastases
Currently open trials in the same condition.
- NCT06548061 — D20054;LITT for Spine Tumors · NA · recruiting
- NCT06244264 — The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis · NA · recruiting
- NCT06120426 — En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor · recruiting
- NCT05575323 — Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases · NA · recruiting
- NCT07429422 — SBRT Technique Implementation for Spinal Metastases Irradiation · NA · recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02320825 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 19 February 2019
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