Clinical trial · Interventional
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
NCT02320825CI-TRIAL-00037159completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high-dose hypofractionated SRS | Radiation | — | UNRESOLVED |
| Quality of Life Measures | Behavioral | — | UNRESOLVED |
| single-fraction SRS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- single-fraction SRS (24 Gy)
- description
- single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
- interventionNames
- Radiation: single-fraction SRS
- Behavioral: Quality of Life Measures
- type
- EXPERIMENTAL
- label
- high-dose hypofractionated SRS (27 Gy in 3 fractions)
- description
- hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.
- interventionNames
- Radiation: high-dose hypofractionated SRS
- Behavioral: Quality of Life Measures
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for MSKCC participants. Institutional pathologic determination accepted from participating multicenter sites.) * Age ≥18 years * Life expectancy ≥3 months * ECOG ≤ 3 * Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks * Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and the spinal cord It should be noted that patients with multiple lesions will be eligible as long as there are no overlapping fields of radiation, including at various time frames. Exclusion Criteria: * Primary spine tumor * Age \< 18 * Pregnancy * Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion * Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine, 5-fluorouracil) given within one week of radiation treatment
References
Publications (0)
Data not yet available
No reference posted for this study.