Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Completed · Phase 3
Conditions studied: Spinal Metastases
In brief
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.
Key facts
- Study ID
- NCT02320825
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 16
- Starts
- 2014-12-16
- Expected to finish
- 2018-07-26
- Last updated by the study team
- 2019-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Stanford University Medical Center — Stanford, California, United States
- John Hopkins Medical Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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