Phase 3
N=16
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Spinal Metastases
Bottom Line
View on ClinicalTrials.gov: NCT02320825 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Feb 2019
Primary outcome: Primary: Local Tumor Control Using MRI or CT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- single-fraction SRS (Radiation); high-dose hypofractionated SRS (Radiation); Quality of Life Measures (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control Using MRI or CT |
— | — |
| SECONDARY Treatment-related Toxicity Using CTCAE v4.0 |
— | — |
| SECONDARY Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02320825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.